BVMed: "The MDR system must now finally be made ready"
According to the Federal Association of Medical Technology, the postponement of the EU Medical Devices Regulation (MDR) decided by the European Parliament on April 17, 2020 is BVMed, “an important step that benefits patients, the healthcare system and the MedTech-helping companies in times of COVID-19 pandemic”. Medical devices can thus be placed on the market for another year under the current legal framework. “The EU Commission must now use the time gained until the new date of application on May 26, 2021 use it consistently to finally get the MDR system ready: We need more notified bodies, the planned expert committees and the necessary legal acts and guidance", demands BVMed-CEO Dr. Marc Pierre moll.
In view of the COVID-19 pandemic, BVMed had called for an MDR moratorium on March 13, 2020. The European Commission's proposal for a regulation to amend the MDR was published on April 3, 2020 and adopted by the European Council on April 7, 2020 for negotiations in the European Parliament. With the decision of the European Parliament, the effective date of the MDR is now being postponed by one year and the bodies designated under the previous legal framework will remain designated for another year. BVMed had also campaigned for the postponement of the transition period, the so-called "Grace Period", and the sell-off period.
"Since only the start of validity is now being postponed by one year, the transition period is actually shortened from 4 to 3 years," notes the MDR expert from BVMed, dr Christine Zimmer, clear. The end date of the transition period remains May 26, 2024, so bottlenecks in May 2024 must be feared. Currently, the new approval of medical devices according to the MDR has come to a standstill due to the COVID-19 pandemic. The guideline published on April 8, 2020 “on temporary extraordinary measures in connection with examinations by the notified body for medical devices during COVID-19” does not provide for remote audits for new certifications and certifications for purpose extensions. “It is currently completely unclear when regular on-site audits can be carried out again. This further shortens the transition period for certain products,” says the BVMed expert.
In the opinion of BVMed, the previous problems with the implementation of the MDR will remain despite the postponement and should be viewed in a different light in view of the COVID-19 pandemic:
- MDR new certifications are currently not being carried out. Nevertheless, other notified bodies must follow. By the end of 2019, the EU Commission had actually announced 20 bodies, of which only 12 have been named to date.
- There are capacity problems with the new certification of products up to the May 2021 deadline, as the notified bodies are focusing on the extension of old certificates during the COVID-19 period. When new certifications will be carried out again depends on the end of the pandemic and the associated travel restrictions.
- Legal acts and important guidelines are missing.
- The Eudamed database was postponed to 2019 at the end of 2022. When it will be effectively functional is completely unclear.
“The consequence: The MedTechindustry is ready, the system is not”, so BVMed-CEO Dr. Marc Pierre moll. “Our companies have already acquired MDR certificates under difficult circumstances, although the system is far from complete. We need to prevent the system from stopping because remote auditing is limited and New certifications and purpose extensions are not feasible. The EU Commission urgently needs to do its homework now.”
Source: Press Release BVMed by 17.04.2020