MDR: number of notified bodies grows

Category: product liability, product safety Industry: healthcare Author: Year:
Miriam Schuh

The number of notified bodies under the MDR is increasing at a faster pace this year. There were 11 notified bodies at the start of the year and this number has grown to 16 in the last six months, including 6 in Germany.

Nevertheless, the designation of notified bodies under the MDR (PDF) has been sluggish overall, especially considering that there were 75 such bodies in 2013, under the MDD (which had lower requirements for notified bodies), and regulatory pressure on the existing 16 notified bodies will be very strong.

The current notified bodies can be viewed here.

[October 2020]