Although the bar was set high in an environment where scrutiny had never been more intense, Notified Bodies stepped up and succeeded with their new designation. The European Commission (EC) on Thursday added one additional Notified Body designated under the new Medical Devices Regulation (MDR). This brings the new total to five. Congratulations!
BSI-UK (0086) www.bsigroup.com 19JAN2019
TÜV SÜD (0123) www.tuev-sued.de/ps 27MAY2019
DEKRA (0124) www.dekra-certification.de 14AUG2019
IMQ ITALY (0051) www.imq.it 20AUG2019
TÜV Rheinland (0197) www.tuv.com/safety 26SEPT2019
For those manufacturers that have received or are about to receive notices that their Notified Body is withdrawing from MDD (or IVDD) and not pursuing MDR certification, huge challenges exist. Your hopes of relying on them to support the soft transition (2020-2024 under MDD or 2022-2024 under IVDD) have disappeared. Manufacturers are given 90 days to find a new Notified Body. How is that going?
The days of “like-to-like” transfers are gone; now it could take up to a year. A potential gap is likely to occur and there are consequences to your device certificates.
The MDR has prescriptive procedures for “Changes to designations and notifications” (see Article 46). Until then, manufacturers today should contact and petition the authority responsible for the Notified Body to identify the legal pathway forward. Procedures will vary by authority and should be considered emergency, temporary measures which will have some restrictions. In some cases, you will be requested to contact the authority where the authorized representative is located or where the manufacturer is located.
What’s been your biggest challenge? Although there are only 243 days left until 26MAY2020, there are still strategies that can be implemented to save your device.
David R Rutledge, Pharm.D., FCCP, FAHA, President & CEO, Global Strategic Solutions, LLC, david.rutledge@globalstrategicsolutions.com