Two new Notified Bodies designated under MDR

The number of Notified Bodies cleared to offer services in accordance with the Medical Device Regulation (MDR, 2017/745) continues to creep up, with two more companies being identified on the NANDO database since the beginning of the year, these being:

• SGS Fimko OY, Finland, and
• Istituto Superiore di Sanita (ISS), Italy

The number of Notified Bodies designated for the In Vitro Device Regulation (IVDR, 2017/746) remains at four, however, with no new designations since November 2020.

Information from the Commission suggests that two further MDR notified bodies will be announced on the NANDO website within the next few weeks, with one further IVDR notified body in a month or two. Currently in process are a further 30 for the MDR and 10 for the IVDR.