In the last years, the EU has significantly revised the legislation covering medical devices to be aligned with the most recent developments in technology and healthcare. One of the main steps taken by the EU institutions was the replacement of the previous MD Directive (MDD) 93/42/EEC and Active Implantable MDD (AIMDD) 90/385/EEC with the Medical Device Regulation (MDR) 2017/745.
According to a report on the availability of Medical Devices published on 14 July 2022 by MedTech Europe, the implementation of MDR is having a serious effect on the EU medical device market, including the transitioning of AIMDD/MDD certificates to the MDR, Notified Body capacity limitations and assessment timelines, and the impact on the availability of medical device innovation in the EU (MedTech Europe, 2022). In particular, MedTech underlines that the “sector remains seriously held back by the slow and piecemeal implementation of the new regulatory framework” and the “continuity of patient access and care are threatened, both in the EU and in the more than 100 countries around the world that rely on European CE marking of medical devices” (MedTech Europe, 2022).
This article aims to determine some of the most relevant challenges related to this issue:
Delay in transition to the MDR
Most devices on the market are yet to transition to the MDR in less than two years remaining until 26 May 2024. The survey justifies this statement based on the following data:
1. More than 85% of the about 500.000 devices estimated to be covered by (AI)MDD certificates have not received the new MDR certificates.
2. Certifications take too much time to be issued by an MDR-designated Notified Body: it takes 13-18 months on average across all devices and company sizes for initial certification.
3. Progress to certification is slow. Around 14% of all certificates (Quality Management System –QMS – and Technical File) have been issued. For large companies and Small and Medium Enterprises (SMEs) with at least some legacy products, on average 83% of their portfolio are ‘legacy’ devices (MedTech Europe, 2022).
Decrease in portfolio
The survey also shows that MDR implementation incentivizes respondents to reduce their portfolio in the brief term. More specifically, 54% declared that they do not intend to transition some of their portfolios to MDR, while it seems that manufacturers’ portfolios will decrease by an average of 20%.
The report underlines that this trend is highly affected by factors such as a substantial increase in costs to recertify under MDR (and general MDR sustaining costs), difficulties linked to clinical evidence for legacy devices, as well as capacity issues at Notified Body level and manufacturer level – due to the unavailable resources as opposed to increased requirements (MedTech Europe, 2022).
A larger effect on SMEs
Another relevant outcome of the research is that the shifting towards MDR is affects more SMEs than big companies. Some data seem to justify this: up to 30% of SMEs have either no Notified Body (15%) and/or have a Notified Body that is not yet designated to MDR (15%); progress to certification for SMEs is slower than average as demonstrates the fact that only 7% of MDR certificates have been issued for them compared to 13% on average.
According to the survey data, while SMEs account for 26% of the total number of devices expected on the market by 26 May 2024, they will require 40% of the total certificates (MedTech Europe, 2022).
Other factors contribute to this general trend, namely the respondents’ choice of geography for the first regulatory approval of new devices and delays in certification due to MDGC guidance.
If you are interested in this topic, you can find the full report here.
Are you interested in knowing more MDR? Do you intend to place your medical devices on the EU market and wish to know about the existing requirements under the EU legislation? Obelis can help you achieve compliance!
EU Council and EU Parliament, 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.). Retrieved on 12/09/2022 from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745.
MedTech Europe. (2022). MedTech Europe Survey Report analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation. Retrieved on 12/09/2022 from medtech-europe-survey-report-analysing-the-availability-of-medical-devices-in-2022-in-connection-to-the-medical-device-regulation-mdr-implementation.pdf (medtecheurope.org).
Obelis Group. Active Implantable Medical Devices Directive. Retrieved on 13/09/2022 from https://www.obelis.net/active-implantable-medical-device-directive/.