Sponsors and Legal Representatives – Clinical Evaluation & Investigation under EU MDR 2017/745

October 3, 2023

July 13, 2024

Table of Contents

Background to Clinical Evaluation & Investigation Requirements

Sponsor of the Clinical Investigation, Perspectives

Sponsor Obligations under EU MDR 2017/745

Overview of Sponsor Obligations

Legal Representatives under EU MDR 2017/745

Takeaways

Background to Clinical Evaluation & Investigation Requirements

The Regulation (EU) 2017/7451 of the European Parliament and of the Council of 5 April 2017 on medical devices – came into effect on 26 May 2021, better known as EU MDR 2017/745 – introduced a set of requirements for conducting clinical evaluation and clinical investigation of medical devices in chapter IV comprising Articles 61 to 80.2

A clinical investigation is defined by EU MDR Article 2(45) as: “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.”

EU MDR defines clinical evaluation and investigation requirements based on the international standard ISO 14155: Clinical investigation of medical devices for human subjects — Good clinical practice3 and MEDDEV 2.7/4: Guidelines on clinical investigation.4

Notably, the ISO 14155 standard will be updated every five years to keep up with the latest advancements in medical device development, and the revised ISO/CD 14155 is under development as we speak, which means that the requirements for clinical evaluation and investigation defined by EU MDR were based on the previous versions of ISO 14155 harmonised5 with the ISO 14155:2020 on 14 April 2021.

Unlike its predecessor, the Medical Device Directive (MDD)6 included one sole article – MDD Article 15: Clinical Investigation – on the subject and identified the manufacturer or the authorised presentative as responsible for the clinical investigation; the EU MDR aims to define the roles and responsibilities of those conducting the clinical investigation.

EU MDR 2017/745 Sponsors and Legal Representatives Clinical investigation sponsor obligations overview

Table 1. Overview of Sponsor Obligations, first published in January 2022 (inXso). 

Takeaways

EU MDR has brought various positive changes in conducting medical device clinical trials in contrast to previous quite outdated MDD as well as the roles of those involved.

The transition period has been long since the European Database on Medical Devices (EUDAMED)8 has not been fully functional. The latest version of EUDAMED 2.12 has been released on 20 September 2023.

Clinical investigation will evolve in the future as international standards, as well as the regulatory framework, keep developing with the science.

References

1. Consolidated text. 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 (Text with EEA relevance) Text with EEA relevance (2023, March 20). The European Commission.https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505

2. Documentation Tool. Regulation (EU) 2017/745 of the European Parliament and of the council. (2017, April 5). The European Commission. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20170505#tocId70 

3. Guidelines on Medical Devices. Guidelines on Clinical Investigation: A guide for manufacturers and notified bodies. MEDDEV 2.7/4 (2015, May 15). European Commission Directorate General for Health and Consumers.  https://www.medical-device-regulation.eu/wp-content/uploads/2019/05/2_7_4_en.pdf 

4. ISO Standard. ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice​. (2020, July). Technical Committee ISO/TC 194 Biological and clinical evaluation of medical devices. https://www.iso.org/standard/71690.html 

5. Commission Implementing Decision. Amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects. (2021, April 14). The European Commission. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021D0611&rid=3

6. Official Journal of the European Communities. Council Directive 93/42/EEC. (1993, June 14, ). The Council of the European Communities. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042

7. Medical Device Coordination Group Document​. MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation. (2021, April). The European Commission. https://health.ec.europa.eu/system/files/2021-04/mdcg_2021-6_en_0.pdf 

8. The Information Center. MDR EUDAMED. (2023, September 20). The European Commission. https://webgate.ec.europa.eu/eudamed/landing-page#/