As I understand it Devices that have a valid CE Mark are able to continue marketing in the EU until 5/26/2021, the new deadline for the new regulations. Since BIEL's CE expired a couple of years ago they need a new certification.
The EU would probably have needed an extension on the 5/26/2020 implementation date with or without the issues Covid-19 presented.
They screwed up the certification of the Notified Bodies that were allowed to handle the new Device Approval Process which caused the log jam that BIEL got caught up in.
Disruption of the Year: EU MDR notified bodies shortage
12/9/2019 Medtech
Many more devices require notified body review under the incoming regulation but there may not be enough firms designated to handle the workload.
Notified bodies in Europe are struggling to keep pace with an increasingly heavy workload ahead of introduction of some of the most significant changes in a generation to the regulation of medical devices in Europe.
An overhaul of European Union medical device regulation is slated to come into play May 26, 2020. MDR has reclassified many devices to a higher risk level and, as a result, a large number will require notified body review— including those that used to be able to self-certify under the older EU directive. On May 26, 2022, the In Vitro Diagnostic Regulation, will come into effect.
But as of Dec. 9, only seven of the entities responsible for certifying devices under the new regs are designated under the MDR. Two of those are also designated under the IVDR.
Part of the challenge is getting accredited under the new rules is a complex and long process. BSI said it took 26 months to get the MDR designation.
More than 35% of organizations responding to a 2019 Regulatory Affairs Professionals Society and KPMG survey said the lack of NBs is a significant impediment, with 91 respondents citing the availability as one of the top barriers to EU MDR compliance.
And 43% of both large and small companies plan on withdrawing or discontinuing products from the EU market because of the new regulation, that survey said. The poll showed more large companies are planning on product withdrawals or discontinuations as a result of the EU MDR than smaller companies, although smaller companies were preparing to withdraw or discontinue more products per company than larger ones.
https://www.medtechdive.com/news/disruption-e...ds/564884/
The EU would probably have needed an extension on the 5/26/2020 implementation date with or without the issues Covid-19 presented.
They screwed up the certification of the Notified Bodies that were allowed to handle the new Device Approval Process which caused the log jam that BIEL got caught up in.
Disruption of the Year: EU MDR notified bodies shortage
12/9/2019 Medtech
Many more devices require notified body review under the incoming regulation but there may not be enough firms designated to handle the workload.
Notified bodies in Europe are struggling to keep pace with an increasingly heavy workload ahead of introduction of some of the most significant changes in a generation to the regulation of medical devices in Europe.
An overhaul of European Union medical device regulation is slated to come into play May 26, 2020. MDR has reclassified many devices to a higher risk level and, as a result, a large number will require notified body review— including those that used to be able to self-certify under the older EU directive. On May 26, 2022, the In Vitro Diagnostic Regulation, will come into effect.
But as of Dec. 9, only seven of the entities responsible for certifying devices under the new regs are designated under the MDR. Two of those are also designated under the IVDR.
Part of the challenge is getting accredited under the new rules is a complex and long process. BSI said it took 26 months to get the MDR designation.
More than 35% of organizations responding to a 2019 Regulatory Affairs Professionals Society and KPMG survey said the lack of NBs is a significant impediment, with 91 respondents citing the availability as one of the top barriers to EU MDR compliance.
And 43% of both large and small companies plan on withdrawing or discontinuing products from the EU market because of the new regulation, that survey said. The poll showed more large companies are planning on product withdrawals or discontinuations as a result of the EU MDR than smaller companies, although smaller companies were preparing to withdraw or discontinue more products per company than larger ones.
https://www.medtechdive.com/news/disruption-e...ds/564884/
