Medical devices play a crucial role in modern healthcare. Their regulation is essential to ensure safety and efficacy. In recent years, regulatory changes in this area had a significant impact on industry and patients. In particular, regulatory requirements and changes in and around the Medical Device Regulation (MDR) are compelling stakeholders to stay on top of the latest developments.
This article summarizes some of the most interesting and consequential news surrounding medical device regulations over the past year. As such, we offer insight into the latest developments and what they mean for the future. Topics covered are problems regarding Notified Bodies, the EU Commission’s plans for EUDAMED and the postponement of MDR transition deadlines.
Problems of the Notified Bodies
Not only medical devices themselves are affected by the MDR, but also those who inspect them. Thus, Notified Bodies must also be re-designated and accredited. From the last 58 Notified Bodies in 2020 under the Medical Devices Directive (MDD), there are currently only 36 under the MDR. . In addition, there are not only new devices that want to be approved, but also legacy devices that need to be re-certified. Considering an outstanding volume of over 17,000 legacy devices that, according to the current transition period, will expire in 2024 and a number of just under 1,300 products certified from April to October 2022, it is obvious that this calculation will not add up. Also, there is a waiting period for certification of 13 to 18 months. Manufacturers and, eventually, patients will suffer from this backlog.
MDR costs for manufacturers
Another MedTech news from 2022 was reported by the news agency “Reuters” and concerns likewise manufacturers and patients. According to the report, some manufacturers cannot afford the costs that arise during the approval of a product. This leads to medical devices being withdrawn from the European market. According to Reuters, this particularly affects pediatric patients and those with rare diseases. Hopefully, a suitable solution to this problem will be found soon.
At the middle of the year, the European Commission announced that full functionality for EUDAMED is targeted for the second quarter of 2024. Initially, the MDR database was expected to be ready as early as 2020. The first module for Actor Registration has already been available since December 2020. In October 2021, the UDI/Product Registration and the module for Notified Bodies and Certificates were also released. Following activation of the remaining three modules in 2024, a transition period of six to 24 months will begin before the use of EUDAMED becomes mandatory.
Postponement of transition periods
Probably the most interesting MedTech novelty of 2022 is the proposal to postpone the MDR transition periods. In December, EU Health Commissioner Stella Kyriakides announced a legislative proposal for early 2023. According to the proposal, the applicable deadlines should be pushed back three and four years, respectively. The deadline for Class IIb and III products would be 2027 and 2028 for Class I and IIa products. Previously, there were concerns from the MedTech industry that the 2024 deadline could lead to a crisis due to the high number of re-certifications. The European Parliament and Council now only need to approve Kyriakides’ proposal for it to be implemented.[Disclaimer]
This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: January 2023)