List of notified bodies updated
The notified body list for the Medical Device Regulation (MDR) has been updated, as HTCert, Cyprus, becomes the latest notified body:
- 3EC International, Slovakia
- AEMPS, Spain
- BSI, Netherlands
- Bureau Veritas, Italy
- Berlin Cert, Germany
- CE Certiso Orvos, Hungary
- Certiquality, Italy
- Dekra Certification, Netherlands
- Dekra Certification, Germany
- DNV Product Assurance, Norway
- DQS Medizinprodukte, Germany
- EMC, Italy
- Eurofins Expert Services, Finland
- Eurofins Product Testing, Italy
- GMED, France
- HTCert, Cyprus
- ICIM, Italy
- IMQ, Italy
- Institute for Testing and Certification, Czech Republic
- Istituto Superiore Di Sanita, Italy
- Italcert, Italy
- Intertek, Sweden
- Kiwa Cermet, Italy
- Kiwa Dare, Netherlands
- MDC Medical Device Certification, Germany
- Medcert, Germany
- National Standards Authority of Ireland (NSAI)
- PCBC, Poland
- SGS, Belgium
- SGS, Finland
- SLG, Germany
- SIQ, Slovenia
- SZUTEST, Germany
- TÜV NORD, Poland
- TÜV SÜD, Germany
- TÜV NORD, Germany
- TÜV Rheinland, Italy
- TÜV Rheinland, Germany
- UDEM Adriatic, Croatia
The notified body list for the In Vitro Diagnostic Device Regulation (IVDR) remains unchanged:
- 3EC International, Slovakia
- BSI, Netherlands
- Dekra Certification, Netherlands
- Dekra Certification, Germany
- QMD Services, Austria
- GMED, France
- MDC Medical Device Certification, Germany
- National Standards Authority of Ireland (NSAI)
- TÜV SÜD, Germany
- TÜV Rheinland, Germany
References
Notified Bodies (IVDR), European Commission: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=legislationId:35,bodyTypeId:3,notificationStatusId:1
Notified Bodies (MDR), European Commission: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=bodyTypeId:3,legislationId:34