German notified body is 13th designated under MDR as MHRA plots delay guidance
Germany’s mdc medical device certification GmbH was designated as the 13th notified body under the EU Medical Devices Regulation (MDR) on Saturday, just one day after the one-year delay to MDR became official.“After a three-year preparation, assessment and approval period, we are proud to have achieved this important goal,” mdc said in a statement. The notified body is also designated under both the EU medical device and in vitro diagnostic directives.
The newly designated notified body is the fourth to be designated in 2020 and the fifth to be designated in Germany. With the implementation date for MDR now kicked back to 26 May 2021, some other notified bodies that were expecting to be designated under MDR later this year may be designated before the regulations take effect. (RELATED: MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020; Notified Bodies Prep for Post-May Designations, Regulatory Focus 11 February 2020).
The MDR delay will also have an impact on the UK, which is currently in the midst of a 10-month transition period during which the former EU member continues to abide by EU law, as the application of MDR will now fall outside the transition period.
On Friday, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said it is “taking steps to plan for after the end of the transition period,” and will be providing guidance on the matter “in due course.”
MHRA says that existing regulatory requirements for devices will continue to apply and that any decision on the regulation “will be taken with a view to prioritising patient safety and ensuring patient access.”
mdc (German), NANDO MDR Database