The European Commission has issued new guidance documents that concern the activities of notified bodies under Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR).
- MDCG 2022-3 provides clarification on verification activities including sample or batch testing for class D IVD medical devices.
- MDCG 2022-4 provides clarification on surveillance activities for certificates of legacy devices under the MDD and AIMDD.
These guidance documents are intended for notified bodies. We would nevertheless strongly suggest manufacturers to review the guidance to obtain a better picture of review and surveillance practices among notified bodies.
Accompanying this subject we recommend the following content on our website
- Key guidance document on the classification of IVDs under the IVDR
- Guidance on Qualification and Classification of Software under the MDR and IVDR Published
- New guidance for third-country manufacturers of COVID-19 IVD tests
- IVDR clinical evidence
- New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits