Will the MDR be delayed again? The EU health commissioner proposed to extend the transition period of the European Medical Devices Regulation (2017/745/ EU) (MDR) to mitigate any short-term risk. Staggered deadlines are proposed: high-risk and low-risk devices would get a new deadline of 2027 and 2028, respectively. It is also suggested to remove the so-called sell-off date of May 2025 to prevent safe medical devices already on the market from having to be discarded.

It is only 18 months away from the end of the transition period of the EU MDR. Since it has been implemented in May 2021, less than 2’000 applications have been approved. At this pace, a total of 7’000 certificates will be issued by the deadline of May 2024, which is only 30% of the total 23’000 devices that are currently certified under the EU Medical Devices Directive. This situation will lead to a shortage of lifesaving equipment in Europe, warn healthcare professionals.

Several reasons have contributed to the current delayed implementation of EU MDR:

• The implementation date has been postponed by one year to May 2021 due to the outbreak of Covid-19 in 2020.
• Notified bodies of lack of capacity due to longer assessment following more stringent regulations.
• The more stringent regulations are also a burden for manufacturers in the preparation of certification documents.
• The cost of compliance with MDR might be 5% or higher of annual revenue, which is extremely expensive for some manufacturers.
• The supply chain disruption caused by the war in Ukraine also created a challenging situation for the manufacturers.