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- Health Canada modifies MDSAP transition process
- MDR/IVDR roadmap published
- FAQ transition timelines MDR/IVDR
- GDPR compliant
- Final text MDR /IVDR for voting
- ISO13485:2016 published
- EU MDR / IVDR publication close
- MDR / IVDR approved
- Standard development
- MDSAP Qualified Auditor
- Virtual Manufacturing of Medical Devices
- LRQA dropping out as Notified Body
- DEKRA Germany 3rd NoBO under MDR
- Worlds first MDR certificate issued by BSI
- US asked to push back the deadline for the new EU MDR requirements.
- TÜV Rheinland 5th Notified Body MDR
- MDCG 2019-11 Software classification in the MDR and IVDR
- DEKRA Certification B.V. designated under MDR
- Will MDR be postponed for a year?
- MDCG 2019-15 Guidance Notes Class I Medical Devices
- "Worst case scenario" MDR and MDD realistic for third countries?
- NSAI 11th Notified Body MDR
- MDCG Offers MDR Implementation Plan, ‘Significant Change’ Guidance
- Update harmonized standards for MDD & IVD directives
- MDR Date of Application 26 May 2021
- ISO/TR 24971:2020 Guidance on the application of ISO 14971
- MDCG 2020-13 clinical evaluation assessment report
- Embracing remote audits
- Eudamed launched with actor registration module live
- Remote Notified Body Audits possible for MDR and IVDR
- MDCG 2021-3 Questions and Answers on Custom-Made Devices (MDR)
- Update references of harmonised standards for medical devices
- Technical Boards of CEN and CENELEC accepted standardization request
- TUV Rheinland Italia designated Notified Body MDR
- New MDCG guidance document MDCG 2021-24
- MDCG 2022-05 Guideline on borderline products
- MDCG 2021-26 Q&A on repackaging & relabelling activities
- Update MDSAP Audit Approach MDSAP AU P0002.007
- Manufacturers approach to the MDR bottleneck around May 2024
- The importance of the device label to a global UDI system
- Submitting Technical Documentation under the MDR?
- Extension of the Medical Devices Regulation (MDR) transition
- Extension of the MDR transitional period
- Notified body capacity
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