The notified body list for the Medical Device Regulation (MDR) has been updated, as RISE MNB, Sweden, becomes the latest notified body:

The notified body list for the In Vitro Diagnostic Device Regulation (IVDR) remains unchanged:

1. 3EC International, Slovakia
2. BSI, Netherlands
3. Dekra Certification, Netherlands
4. Dekra Certification, Germany
5. QMD Services, Austria
6. GMED, France
7. MDC Medical Device Certification, Germany
8. National Standards Authority of Ireland (NSAI)
9. TÜV SÜD, Germany
10. TÜV Rheinland, Germany
11. Eurofins Electric & Electronics, Finland
12. Sertio Oy, Finland

References

Notified Bodies (IVDR), European Commission: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=legislationId:35,notificationStatusId:1

Notified Bodies (MDR), European Commission: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=legislationId:34,notificationStatusId:1

References

European Commission, “Availability and capacity of notified bodies to carry out conformity assessments for Covid-19 related medical devices and in vitro diagnostic medical devices”: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_survey-conformity-assess-covid-19.pdf