MedTech Europe, the trade association representing medical technology industries, has called for an extension of transition period before the application of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). The MDR and IVDR are scheduled to come into full effect on the 26 May 2020 and 2022 respectively.
The current European legislation regulating medical devices is based on directives first implemented in the early 1990s. Whilst the system is fundamentally effective, gaps in the legislation have led to patients being exposed to faulty products, and it is difficult for authorities within member states to share information with each other. Furthermore, there are concerns that the standard of scrutiny provided by Notified Bodies within member states is not consistent throughout the union, leading to insufficient information on a device’s effectiveness or safety. Consequently, the new regulations, which were published in May 2017 aim to provide:
- Uniform control of Notified Bodies
- Enhanced legal clarity and coordination in post-market safety
- A uniform solution for “borderline” cases
- Enhanced transparency and traceability of medical devices on the EU market
- Greater involvement of external scientific and clinical expertise
- Clearer explanations of the obligations and responsibilities of economic operators, including diagnostic services and internet sales
- Governance – efficient and effective management of the regulatory system
- Introduction of unannounced inspections
- Introduction of a Unique Device Identifier (UDI)
However, in a four-page position paper, MedTech Europe highlights significant industry concerns about the extent to which preparations for the new regulations have been fully implemented. In particular, MedTech Europe highlights:
- Poor progress in re-designating Notified Bodies.
- Only 2 of the 18 system critical implementing acts have been published.
- Expert panels and common specifications are needed for certain new high-risk products.
- Standards and guidelines are required to provide a common interpretation of the new rules for industry.
- The new Eudamed database for medical devices must be ready on time.
- Notified bodies will be unable to cope with the high demand for the renewal of certificates for devices which no longer comply with the regulations, and hope to stay on the market until the ‘Grace Period’ ends in May 2024.
To mitigate these issues, MedTech Europe proposes:
“Actions to address challenges on the transition timing:
- A ‘stop the clock’ mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved;
- An extension of the critical dates of 26 May 2020 and 26 May 2022, for all products;
- An extension of the critical dates of 26 May 2020 and 26 May 2022, for legacy products only.
Actions to make the ‘grace period’ an effective instrument and overcome the bottlenecks:
- Extending its scope to include all products and particularly the legacy products;
- Having a more feasible and flexible timing.”
To read the position paper in full, click here. You can also read MAPs comprehensive sections on the new regulations in detail here.