Iso 14155:2011 free download

Headquartered in Ireland, StatisticaMedica has extensive knowledge, experience and exposure to the complexities and nuances of the various health environments across Europe and North America. We focus on enhancing the quality of the data to support the effective delivery of results through each step of the development process, from bench work to clinical trials and observational studies. Aleph offers advisory services in such fields as information communication technology, data management, and statistical analysis.

Besides, Aleph acts as a CRO. In particular, the company provides tools and services to satisfy the needs of those who specialise in pharmaceutics and biomedicine and of those who conduct research within non-profit organisations.

Exom is a globally acting full-service CRO committed to the modernization of clinical trials through implementation of innovative digital solutions. As data-driven and quality-focused clinical CRO, OPIS collaborates with numerous international Sponsors on multi-country interventional as well as non-interventional trials. OPIS teams have sound experience in a wide range of therapeutic areas, new-generation drugs, advanced therapeutic procedures and biologic treatment options.

AmberCRO delivers high-quality services in the field of clinical research by conducting clinical trials phase I-IV in different therapeutic areas. The vision of the company is to become the most reliable partner to pharmaceutical companies, CROs and health care professionals in Northern part of Europe Baltic States , Belarus and in Caucasus region Georgia, Armenia.

BalticCRO is a functional outsourcing and consultancy services provider for pharmaceutical companies, multinational CROs and service providers that require local presence and support. We are operationally focused on providing country-level clinical research, pharmacovigilance, regulatory affairs, product reimbursement and market access services. Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in clinical trials, regulatory affairs and pharmacovigilance.

The company has significant presence across the CEE, Nordic and CIS countries thereby offering fast and reliable patient recruitment for Phase I-IV and medical device clinical trials, while regulatory and pharmacovigilance services are provided across 4 continents. Our expertise is providing full service, assistance and advice for medical scientific research in human beings in Europe: submission of clinical trials in order to obtain approval of the ethics committees and competent authorities; clinical trial set-up, execution, and monitoring; advice and consultancy; education and training of investigators, team members and research teams in regulations like ICH-GCP, ISO combined with daily practice; and the conduct of home care visits for clinical trials by research nurses.

CR2O offers the full range of clinical trial services, including clinical trial management, grant proposal development, pharmacovigilance and medical monitoring, quality management and auditing, regulatory strategy and affairs, data management and biostatistics, insourcing, and medical and scientific writing. Since its inception in , Curve Clinical has worked on more than 30 clinical studies. Curve Clinical has extensive experience with complex and logistically challenging clinical trials.

Julius Clinical offers end-to-end CRO services in specific therapeutic areas. We are also able to manage all aspects of sites — from selection of sites to administration. Julius Clinical is specialised in distinct therapeutic areas including cardio and metabolic, infectious diseases, immunology and brain, and can offer a full service proposal or separate functional services as required.

Our expertise ranges from early phase to post registration, and we advocate use of RWE if this enhances the outcome of the project.

Siron Clinical offers unparalleled knowledge, support, guidance, and extremely experienced clinical research professionals to the biotechnology, life science, and medical device industries. Our core competence is expert consulting related to the clinical development plan and specifically to proof-of-concept trials phase IIa , thus in clinical development where biomarkers play a pivotal role.

Our functional services are primarily focused on clinical project management and monitoring of phase II-III studies, regulatory affairs, data management, statistics, medical writing and general drug development consulting. LINK Medical is a full-service contract research organization CRO providing product development services for the pharmaceutical and medical device industries across Northern Europe.

Our dedicated team provides specialist expertise across every aspect of a project, from early development to post-marketing — all from ONE source. Brillance Sp. Our activities are focused on research and development services for medical, pharmaceutical and biotechnology industries. The comprehensive range of professional services offered by Brillance includes monitoring and management of phase I-IV clinical trials and includes both local and big international complex projects in many therapeutic areas.

Clinical Consulting was founded in and provides clinical operation services in Poland, focused on managing phase I-IV clinical trials. We have achieved rapid growth that continues to date. Our services are based on the focus we give to our customers, growing and progressing experience, reliability and resources. Our clinical operation services include clinical trial monitoring, project management, post-marketing surveillance studies, and regulatory submissions.

Clinmark is a leading full-service CRO specializing in clinical research and global clinical consulting since Clinmark is committed to providing support for pharmaceutical and biotechnological companies in the area of research and development through operational activities, professional auditing, consulting and education. Our reliability comes from unique consulting skills developed and practiced for several years in more than consulting and audit projects in nearly 75 countries.

We provide state-of-the art, cost effective clinical trial services to pharmaceutical and biotechnology companies. We also provide contract and personnel services to other CROs and medical universities. Currently, we provide clinical trial service for big pharmaceutical companies Sanofi, AbbVie, Takeda and others. Over the years, we have completed projects in the fields of cardiology, endocrinology, gastroenterology, pulmonology, pediatrics, nephrology, gynecology, oncology, neurology, rheumatology, and orphan diseases.

Rocketpharm is a Polish Contract Research Organization providing clinical research services for pharmaceutical, biotech and CRO companies in drug and device clinical trials, including feasibility, regulatory and EC submission, study start-up, monitoring, close-out activities and CRA outsourcing. A key strength of CETERA is the academic expertise and integrity of its scientific team which lies in a global coverage with different stakeholders.

CETERA provides a wide range of services, from scientific consulting and regulatory expertise to the management of national and international clinical research trials.

Scientific ToolBox Consulting is a Contract Research Organization CRO that provides a wide variety of scientific consulting services for designing, implementing, conducting, managing, analysing and reporting clinical research clinical trials, observational, epidemiological and pharmacoepidemiological studies.

Privately owned full-service CRO with consistent experience in Romania, able now to offer the highest level of expertise in providing clinical operations services. Our main activity is to conduct clinical research in bioequivalence studies and clinical trials of phase II-IV in Romanian sites. Through our offices the SMP personnel provides full monitoring and study coordination services in Romania.

Our services include study budgeting, feasibility, site recruitment, regulatory affairs, ethics committee submissions, drug import, site initiation, project management, monitoring, data management, and biostatistics.

As a Contract Research Organization, we manage projects from start to finish. Services include selection of study sites, regulatory and ethics committee submissions, study monitoring, study feasibility, EDC solutions, administration of investigator payments, and CRA outsourcing.

Clinitria is a company established by experienced professionals with many years of experience in pharmaceutical, medical device development and biomedical research in Western Europe. The company was established in We are able to identify and contract investigators for Phase I to Phase IV studies, identify and contract pre-clinical units, organize investigator meetings and scientific congresses and symposia, perform study setup, monitoring or auditing of clinical trials.

Clinres, Ltd. For more than seven years we have been performing clinical studies of phase I-IV for the biggest pharmaceutical companies and international CROs. Furthermore, that nomenclature should be available, where reasonably practicable, free of charge also to other stakeholders.

Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on performance studies should serve as a tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and to report serious adverse events, device deficiencies and related updates.

The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of the evaluation of such incidents and events by competent authorities.

The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. For class C and D devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the performance evaluation in a document that should be publicly available.

The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level.

Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on performance evaluation, should be critically evaluated by the authority responsible for notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities of notified bodies and should be based on sampling of the relevant documentation. To increase transparency with regard to the oversight of notified bodies by national authorities, the authorities responsible for notified bodies should publish information on the national measures governing the assessment, designation and monitoring of notified bodies.

In accordance with good administrative practice, this information should be kept up to date by those authorities in particular to reflect relevant, significant or substantive changes to the procedures in question. The Member State in which a notified body is established should be responsible for enforcing the requirements of this Regulation with regard to that notified body.

In view, in particular, of the responsibility of Member States for the organisation and delivery of health services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for the conformity assessment of devices and established on their territory as far as issues that are not regulated in this Regulation are concerned.

Any such additional requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal treatment of notified bodies. For class D devices, competent authorities should be informed about certificates granted by notified bodies and be given the right to scrutinise the assessment conducted by notified bodies. For class D devices for which no CS exist it is appropriate to provide that where it is the first certification for that specific type of device and there is no similar device on the market having the same intended purpose and based on similar technology, notified bodies should, in addition to the laboratory testing of the performance claimed by the manufacturer and the compliance of the device by the EU reference laboratories, be obliged to request expert panels to scrutinise their performance evaluation assessment reports.

The consultation of expert panels in relation to the performance evaluation should lead to a harmonised evaluation of high-risk in vitro diagnostic medical devices by sharing expertise on performance aspects and developing CS on categories of devices that have undergone that consultation process.

It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in four risk classes and to establish a set of robust risk-based classification rules, in line with international practice.

The conformity assessment procedure for class A devices should be carried out, as a general rule, under the sole responsibility of manufacturers, since such devices pose a low risk to patients. For class B, class C and class D devices, an appropriate level of involvement of a notified body should be compulsory.

The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field.

It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity.

It is necessary to clarify the requirements regarding batch release verification for the highest risk devices. EU reference laboratories should be enabled to verify by laboratory testing the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.

To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical evidence. It is necessary to clarify the requirements for the demonstration of the clinical evidence, that is based on data on scientific validity, and the analytical performance and clinical performance of the device.

To allow for a structured and transparent process, generating reliable and robust data, sourcing and assessment of available scientific information and data generated in performance studies should be based on a performance evaluation plan.

As a general rule, clinical evidence should be sourced from performance studies that have been carried out under the responsibility of a sponsor. It should be possible both for the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the performance study. It is necessary to ensure that the clinical evidence of devices is updated throughout their lifecycle.

Such updating entails the planned monitoring of scientific developments and changes in medical practice by the manufacturer. Relevant new information should then trigger a reassessment of the clinical evidence of the device thus ensuring safety and performance through a continuous process of performance evaluation. Where specific devices have no analytical or clinical performance or specific performance requirements are not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions relating to such requirements.

The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies conducted outside the Union in accordance with international guidelines to be accepted within the Union.

It should be left to the Member State where a performance study is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a performance study and to organise the involvement of ethics committees within the timelines for the authorisation of that performance study as set out in this Regulation.

Such decisions are a matter of internal organisation for each Member State. In that context, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the necessary expertise is available. An electronic system should be set up at Union level to ensure that every interventional clinical performance study and other performance study involving risks for the subjects of the studies is recorded and reported in a publicly accessible database.

To ensure synergies with the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use. Where an interventional clinical performance study or another performance study involving risks for the subjects is to be conducted in more than one Member State, the sponsor should have the possibility of submitting a single application in order to reduce administrative burden.

In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the device for performance study and of the scientific design of that performance study, the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State.

Such coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a performance study, including informed consent.

For an initial period of seven years from the date of application of this Regulation, Member States should be able to participate on a voluntary basis in the coordinated assessment. After that period, all Member States should be obliged to participate in the coordinated assessment.

The Commission, based on the experience gained from the voluntary coordination between Member States, should draw up a report on the application of the relevant provisions regarding the coordinated assessment procedure. In the event that the findings of the report are negative, the Commission should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment procedure. Sponsors should report certain adverse events and device deficiencies that occur during interventional clinical performance studies and other performance studies involving risks for the subjects to the Member States in which those studies are being conducted.

Member States should have the possibility of terminating or suspending the studies or revoking the authorisation for those studies, if considered necessary to ensure a high level of protection of the subjects participating in such studies.

Such information should be communicated to the other Member States. The sponsor of a performance study should submit a summary of results of the performance study that is easily understandable for the intended user together with the performance study report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results will be submitted.

With exemption of some general requirements, this Regulation should only cover performance studies intended to gather scientific data for the purpose of demonstrating conformity of devices. It is necessary to clarify that performance studies using left-over specimens need not be authorised.

Nevertheless, the general requirements and other additional requirements with regard to data protection and the requirements applicable to procedures that are performed in accordance with national law such as ethical review should continue to apply to all performance studies, including when using left-over specimens.

In particular, the unnecessary duplication of tests and studies should be avoided. Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities.

To that end, manufacturers should establish a comprehensive post-market surveillance system, set up under their quality management system and based on a post-market surveillance plan. In order to better protect health and safety regarding devices on the market, the electronic system on vigilance for devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions.

Member States should take appropriate measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be encouraged and enabled to report suspected serious incidents at national level using harmonised formats.

The national competent authorities should inform manufacturers of any suspected serious incident and, where a manufacturer confirms that such an incident might have occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents. The evaluation of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective action.

In the context of the investigation of incidents, the competent authorities should take into account, where appropriate, the information provided by and views of relevant stakeholders, including patient and healthcare professionals' organisations and manufacturers' associations.

The reporting of serious adverse events or device deficiencies during interventional clinical performance studies and other performance studies involving risks for the subjects, and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.

Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures.

Any statistically significant increase in the number or severity of incidents that are not serious or in expected erroneous results that could have a significant impact on the benefit-risk analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to permit their assessment and the adoption of appropriate measures.

The MDCG should be able to establish subgroups in order to have access to necessary in-depth technical expertise in the field of medical devices including in vitro diagnostic medical devices.

When establishing subgroups, appropriate consideration should be given to the possibility of involving existing groups at Union level in the field of medical devices. Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is essential for ensuring a uniform high level of health and safety protection within the internal market, in particular in the areas of performance studies and vigilance.

The principle of coordinated exchange and assessment should also apply across other authority activities described in this Regulation, such as the designation of notified bodies and should be encouraged in the area of market surveillance of devices. Joint working, coordination and communication of activities should also lead to more efficient use of resources and expertise at national level. The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly implemented at Union level based on sound scientific evidence.

The Union and, where appropriate, the Member States should actively participate in international regulatory cooperation in the field of devices to facilitate the exchange of safety-related information regarding devices and foster the further development of international regulatory guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that set by this Regulation. Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement.

Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should, in order to ensure transparency, inform the Commission and the other Member States before they decide on the level and structure of such fees.

In order to further ensure transparency, the structure and level of the fees should be publicly available on request. This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property.

This Regulation should be applied by the Member States in accordance with those rights and principles. The power to adopt delegated acts in accordance with Article TFEU should be delegated to the Commission in order to amend certain non-essential provisions of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April on Better Law Making In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with preparation of delegated acts.

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. The advisory procedure should be used for implementing acts that set out the form and presentation of the data elements of manufacturers' summaries of safety and performance, and that establish the model for certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an impact on health and safety at Union level.

The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures, imperative grounds of urgency so require. In order to enable it to designate issuing entities and EU reference laboratories, implementing powers should be conferred on the Commission.

To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements that are to be made.

However, certain parts of the Regulation that directly affect Member States and the Commission should be implemented as soon as possible. It is also particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be designated in accordance with the new requirements so as to avoid any shortage of devices on the market.

In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the obligation to submit the relevant information to the electronic systems set up at Union level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to plan, only become fully effective from 18 months after the date of application of this Regulation.

However, in order to avoid multiple registrations, economic operators and notified bodies who register in the relevant electronic systems set up at Union level pursuant to this Regulation should be considered to be in compliance with the registration requirements adopted by the Member States pursuant to those provisions.

In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned.

Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to that Directive should however continue to apply.

While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting adverse incidents related to devices placed on the market pursuant to that Directive using the same tools as those for reporting on devices placed on the market pursuant to this Regulation.

The requirements of this Regulation should be applicable to all devices placed on the market or put into service from the date of application of this Regulation. Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal market as regards medical devices and to ensure high standards of quality and safety for in vitro diagnostic medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.

In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,. Scope and definitions. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union.

The requirements of this Regulation shall apply to the in vitro diagnostic medical device part. This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation. This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or health care institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling.

Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose;. A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study;.

Regulatory status of products and counselling. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 3 of this Regulation. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 3. The Commission shall ensure that Member States share expertise in the fields of in vitro diagnostic medical devices, medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products.

When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency EMA , the European Chemicals Agency and the European Food Safety Authority, as relevant.

Nothing in this Article shall prevent Member States from adopting or maintaining measures at national level which are more protective of patients, more specific or which deal with informed consent. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.

A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose. Demonstration of conformity with the general safety and performance requirements shall include a performance evaluation in accordance with Article Devices that are manufactured and used within health institutions, with the exception of devices for performance studies, shall be considered as having been put into service.

With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:.

Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory.

Member States shall retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.

This paragraph shall not apply to devices that are manufactured on an industrial scale. In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned.

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:.

Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union , shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.

References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union. References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, provided that references to those monographs have been published in the Official Journal of the European Union.

Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications CS in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the performance evaluation and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annex XIII.

Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.

Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. Manufacturers shall draw up and keep up to date the technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed.

The Commission is empowered to adopt delegated acts in accordance with Article amending, in the light of technical progress, the Annexes II and III. Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devices for performance study, shall draw up an EU declaration of conformity in accordance with Article 17, and affix the CE marking of conformity in accordance with Article Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 24 and with the registration obligations referred to in Article 26 and Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market.

Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof. A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11 3 , ensure that the authorised representative has the necessary documentation permanently available.

Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a product is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than devices for performance study, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.

Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language s determined by the Member State in which the device is made available to the user or patient.

NSAI has published I. EN ISO - " Clinical investigation of medical devices for human subjects — Good clinical practice" , which supersedes the version of the Standard. Both Technical Committees develop Standards for the biological and clinical evaluation of medical devices. The scope of the Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

While the new version is not currently listed in the European Commission's mandate to CEN to develop Standards supporting the Medical Device Regulation, it is expected the list will be updated to include the latest version.