Proposal for a Regulation amending the MDR and IVDR
The declared objectives of the new version of the legal framework for medical devices and in vitro diagnostics in the form of the European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), which entered into force in 2017, were to improve patient safety and promote innovative products. With the significantly stricter requirements for economic operators and products, the need for accreditation of already lacking Notified Bodies with respect to the new regulations, and the additional documentation effort required, the opposite seems to have occurred. In particular, “niche” products, especially those required for pediatric medicine, are no longer being manufactured because the increased requirements no longer make it profitable to continue producing small quantities. Existing products cannot continue to be placed on the market because “old” certificates of Notified Bodies will not be able to be renewed (in time) in the foreseeable future. New, innovative products fail because of the time-to-market “distance” that results from longer conformity assessment procedures and the associated costs. The strain on the industry in connection with the Corona pandemic has had a further negative impact on the unfavourable incongruous situation. As a result, there has been and continues to be a risk of shortages of essential and new medical devices, which neither increases patient safety nor promotes product innovation.
To address these abuses, the EU Commission’s proposal to amend the MDR and IVDR therefore provides for the following:
1. Extension of the transition periods
For medical devices for which a certificate or declaration of conformity was issued before 26 May 2021, the transition period to the new regulations will be from 26 May 2024 to 31 December 2027 for higher-risk devices (Class III and
Class IIb implantable devices, with the exception of certain devices for which the MDR provides exemptions) and extended until 31 December 2028 for moderate- and lower-risk devices (Class IIb devices and Class IIa, Im, Is, and Ir devices). A transition period until 26 May 2026 will be introduced for Class III implantable custom devices to give manufacturers more time to obtain certification from a Notified Body.
- Class III and IIb implants à new deadline 31 December 2027
- Class IIb and lower à new deadline 31 December 2028
- Class III custom-made products à new deadline 26 May 2026
However: The extension is subject to certain conditions. Only products that are safe and for which manufacturers have already taken steps to transition to the Medical Device Regulations will benefit from the additional time.
2. Waiver of “sell by” date
The Commission also proposes to eliminate the “sell by” date currently provided for in Article 120(4) MDR and Article 110(4) IVDR. This is the end date after which products that have already been placed on the market and are still available for purchase should be withdrawn. The elimination of this cutoff date is now intended to ensure that safe and essential medical devices already on the market continue to be available to health care systems and patients in need.
The proposal on the amendments must be adopted by the European Parliament and the Council. An accelerated co-decision procedure is stipulated for this purpose.
The proposed changes are reasonable and may result in “relief” for manufacturers who will benefit from longer timelines to achieve MDR/IVDR compliance of their products. They will also help avoid bottlenecks in medical device supply. At the same time, the changes do not give manufacturers carte blanche! Manufacturers must consider on a case-by-case basis whether the extended transition periods can actually be applied to their products and continue to work to achieve MDR/IVDR compliance as quickly as possible.back