Medical Devices Regulation

by Amaya Erce
Senior Consultant Amaya Erce looks into what the future of medical devices regulation holds

Medical devices: the work has only started

On 26 May, after a long running process of five years, entered into force the much-awaited Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). In a simple and ideal world the end of the legislative phase would close the overall process; in Brussels it marks the beginning of the nitty-gritty work.

How is this possibly the case after such exhaustive and long regulations? If you are thinking this, I am sorry to tell you that the effective application of the MDR and IVDR requires now an important number of additional supporting quasi-legislations: implementing and delegated acts. These, often referred to in the EU as "tertiary legislation” or “comitology”, will be drafted and adopted by the European Commission (indirectly supported by the Member States and, in the case of delegated acts, under the scrutiny of European Parliament and Council of the European Union) during the transition period, that is, the three years after the date of the entry into force.

For files as technical as the MDR and the IVDR to function correctly, over 80 delegated and implementing acts are foreseen to be drafted and adopted. They will cover numerous aspects such as definitions, the regulatory status of products, common specifications in respect of the general safety and performance requirements, conformity assessment procedures, Unique Device Identification (UDI) system rules, the requirements for the application for clinical investigations and a long etcetera.

They will provide the “how” and the “what”: implementing acts will set the procedural rules to facilitate the implementation into the different Member States (HOW) whereas delegated acts will supplement or amend certain provisions of the newly adopted legislation (WHAT).

While the content of the latter may be seen as more politically sensitive, one must not disregard the impact of implementing acts. Both are of tremendous interest for stakeholders, maybe even as much as the pure legislative process, since they will allow to clarify technical requirements and supplement or clarify elements of the legislative acts. This is why they are anticipated to play a role in the final implications for authorities and notified bodies as well as to have a very concrete impact on the industry.

For further information on how to keep track of any development and maximise the opportunities in this scenario, please don’t hesitate to contact us at RPP Healthcare.