The Survival Guide to EU Medical Device Regulations

Petri Pommelin

• Publisher: Books on Demand
• Year: 2017
• Print ISBN:
  9789515681201
• eBook ISBN:
  9789515686824
• Edition: 1
• Topic: Politica e relazioni internazionali
• Subtopic: Politica

The Regulations for medical devices and in vitro diagnostic medical devices were published in the Official Journal of the European Union on 5 May 2017, and they entered into force 26 May 2017. A regulation is a legal act of the European Union that becomes immediately enforceable as law in all Member States simultaneously. This book gives guidance on the definitions, the key concepts and the main elements. The intention is to provide an introduction that supports the further reading of the challenging content of the Regulations.

1. Where are we coming from?

The time of harmonised EU legislation for medical devices began January 1, 1995. It was the end of the transitional period of the AIMDD and the start of the transitional period of the MDD. The manufacturers of medical devices experienced the first challenge of adapting their operational systems to the new provisions and procedures. The deadline was June 14, 1998.

Simultaneously, the drafting of the IVDD was launched. The IVDD was adopted December 7, 1998, and enforced June 7, 2000 with transitional period ending December 12, 2005. The Commission issued two Directives on reclassification of breast implants (2003) and hip, knee and shoulder joint replacements (2005). The BSE issue resulted in the Commission Directive (2003) on medical devices manufactured utilising tissues of animal origin. Some of the major shortcomings of the MDD and the AIMDD were repaired by the Directive 2007/47/EC.

The IVDD was supplemented by three Commission Decisions on Common Technical Specifications (2002, 2009 and 2011) and the Commission Directive on Variant Creutzfeld-Jakob Disease assays (2011). The Commission Regulation on medical devices manufactured utilising tissues of animal origin was issued in 2012. The infrastructure of the EU regulatory framework was improved by the Commission Decision on the European Databank on Medical Devices aka Eudamed (2010) and the Commission Implementing Regulation on the designation and the supervision of notified bodies (2013). In addition, the Commission has published during the years several legally non-binding guidance documents (MEDDEVs), consensus statements and informative documents that pursue the objective of ensuring uniform application of the relevant provisions of the directives within the EU.

Problems with diverging interpretation of the Medical Device Directives as well as some incidents with breast implants and metal hip implants highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. In September 2012, the European Commission finally published the proposals for the Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

Thus a fundamental revision of these Directives was needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation (MDR Recital 1, IVDR Recital 1).

On 5 April 2017, two new Regulations on medical devices (MDR¹ and IVDR²) were adopted replacing the existing three Directives (AIMDD, MDD and IVDD).

This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. (MDR Recital 2, IVDR Recital 2)

This Regulation sets high standards of quality and safety for medical devices by ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected. (MDR Recital 2)

This Regulation sets high standards of quality and safety for in vitro diagnostic medical devices by ensuring, among other things, that data generated in performance studies are reliable and robust and that the safety of subjects participating in performance studies is protected. (IVDR Recital 2)

2. Where are we going from here?

A directive is a form of legislative act addressed to the EU Member States. The directive binds the Member State to reach certain objectives in their national legislation. In practice Member States are required to make changes to their laws (commonly referred to as transposition) in order for the directive to be implemented correctly.

A regulation is a legal act of the EU that becomes immediately enforceable as law in all Member States simultaneously. When a regulation comes into force, it overrides all national laws dealing with the same subject matter and subsequent national legislation must be consistent with and made in the light of the regulation.

The MDR and the IVDR introduce a life-cycle approach and takes into account the guidance developed for medical devices at international level. This approach also incorporates some existing European guidance (MEDDEVs³), i.e. the Guidance on Authorised Representation, Vigilance System, Post-Market Clinical Follow-Up and Clinical Evaluation, into the regulations.

Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety. (MDR Recital 4, IVDR Recital 4)

To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical investigations. (MDR Recital 5, IVDR Recital 5)

There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned. (IVDR Recital 5)

As the MDR and the IVDR were published in the EU Official Journal on 5 May 2017 it meant that the transitional periods under the regulations started 26 May 2017. The chapter 18 of this guidance gives more information on the transitional provisions.

STEP 1

Find the regulations in suitable language from the web site of the EU Official Journal^4 and start the exploration.

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¹ Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

² Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

³ http://ec.europa.eu/growth/sectors/medical-devices/guidance_en

⁴ http://eur-lex.europa.eu/oj/direct-access.html

3. How to read the regulations?

The MDR and the IVDR are organised into Recitals, which are explanatory in nature and not legally binding, Chapters which are comprised of Articles, and Annexes. The MDR consists of 101 recitals, 10 Chapters, 123 Articles and 17 Annexes. The IVDR consists of 101 recitals, 10 Chapters, 113 Articles and 15 Annexes (Figure 1). The MDR text published in the EU Official Journal consists of 175 pages and the IVDR of 157 pages. The titles of the Annexes of both Regulations are presented in Appendix 1.

It is strongly recommended to study the definitions of the key concepts before you start reading the text. The definitions are given in the Article 2 of both the regulations. Most of the definitions are the same but there are also some that are specific to the MDR and the IVDR respectively. The comparison of the definitions of the MDR and the IVDR is illustrated in Figure 2. All the definitions are presented in Appendix 2.

Figure 1 The structure of the MDR and IVDR

The definition of ‘medical device’ (Figure 3) is extended to include products for cleaning, disinfection or sterilization. Previously, products used for cleaning, disinfection or sterilization were accessories to medical devices and hence accessories to cleaning, disinfection or sterilization products were not within the remit of the directive.

It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device. (MDR Recital 19, IVDR Recital 17)

The MDR shall also apply to a specific group of devices that do not meet the exact definition of medical devices but may have a ‘medical character’. These devices are listed in Annex XV of the MDR.

Certain groups of products for which a manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation. In order for manufacturers to be able to demonstrate the conformity of such products, the Commission should adopt common specifications at least with regard to application of risk management and, where necessary, clinical evaluation regarding safety. Such common specifications should be developed specifically for a group of products without an intended medical purpose and should no...

Table of contents

• Table of Contents
• Introduction
• 1. Where are we coming from?
• 2. Where are we going from here?
• 3. How to read the regulations?
• 4. Placing on the market and putting into service
• 5. General safety and performance requirements
• 6. Risk management system
• 7. Harmonised standards and common specifications
• 8. Economic operators
• 9. Technical documentation
• 10. Notified bodies
• 11. Clinical evaluation
• 12. Classification of devices
• 13. Conformity assessment
• 14. Traceability of devices
• 15. Registration procedures and Eudamed
• 16. Post-market surveillance
• 17. Publication of information
• 18. Transitional provisions and entry into force
• Appendix 1: Annexes of the MDR and the IVDR
• Appendix 2: Definitions of the MDR and the IVDR
• Appendix 3: Comparisons of subject matter and scope
• Appendix 4: Annex I of the MDR compared to the MDD
• Appendix 5: Annex I of the IVDR compared to the IVDD
• Appendix 6: Classification rules of the MDR
• Appendix 7: Classification rules of the IVDR
• Appendix 8: Technical documentation (MDR)
• Appendix 9: Technical documentation (IVDR)
• Appendix 10: EU declaration of conformity
• Copyright