In this blog post, you will get an introduction to the requirements for medical device certification under the new EU Medical Device Regulation (MDR).
In this blog post, you will get an introduction to the requirements for medical device certification under the new EU Medical Device Regulation (MDR).
Amendment MDR Status May 2021
Certification of medical devices under the new EU Medical Device Regulation (MDR) is a challenge for many manufacturers. The MDR, which goes into effect May 26, 2021, will require manufacturers to comprehensively overhaul their approval processes and make a significant investment in compliance with the new rules. According to the MDR, the import of medical devices and IVDs into the Swiss market the official appointment of a Swiss authorized representative.
Product shortage as a result
Due to the high requirements and scope of the changeover, many manufacturers are having difficulty meeting the deadlines. This has led to bottlenecks in the approval of medical devices and a shortage of important products on the market. To address this issue, the EU Commission has adopted a proposal to allow more time for certification of medical devices under the MDR. The proposal is to extend the validity of MDD certificates and to introduce a longer transition period for adaptation to the new MDR rules. However, the extension of the deadlines is subject to certain conditions, so that more time will only be granted for products that are safe and for which manufacturers have already taken steps to transition to the MDR regulations.
The EU Commission grants an extension of the transition period for medical devices.
Solution approach of the EU Commission
The EU Commission’s proposal includes an extension of the transition period for medical devices in the lower risk classes (Ix and II, with the exception of IIb implantable) until December 31, 2028. For medical devices in the higher risk classes (IIb implantable and III), the deadline is extended to December 31, 2027. A transition period until May 26, 2026, is proposed for Class III implantable custom devices.
In addition, the Commission proposes to remove the “sell-by” period currently set forth in the MDR and IVDR. This deadline specifies that products certified after the MDR or IVDR certification expiration date must be sold within 18 months. This regulation may lead to unnecessary waste of medical devices and affect the supply of essential products.
Extending the deadlines for medical device certification under the MDR is an important step in avoiding bottlenecks in medical device approvals and ensuring that important products are available on the market. However, the extension of the deadlines is subject to certain conditions to ensure that only products with a high safety standard and a conversion process already underway are given more time. The proposal must now be adopted by the European Parliament and the Council in order to enter into force.
(Source: https://ec.europa.eu/commission/presscorner/detail/de/ip_23_23)
