New updates on MDR and IVDR specific to their progress
Methodize has some new developments to share in regards to the progress of the draft MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) documents, as well as a new revision of the MEDDEV guidance document on Clinical Evaluation Reports (CERs), which is significant for all medical device manufacturers in the EU market under the MDD 93/42/EEC.
MEDDEV 2.7/1, Rev. 4 on Clinical Evaluation Report Criteria
The European guidance on CERs has been revised in June. The new version is available as MEDDEV 2.7/1, Rev. 4 on the EU Commission website at the following link http://ec.europa.eu/growth/sectors/medical-devices/guidance/index_en.htm . While it’s not possible to provide a complete review of the revisions here, in particular, the guidance is much more extensive and comprehensive in comparison to the prior 2009 version and discusses use of the CER as an exercise in advance of performing a clinical investigation, if necessary. The process described much more closely aligns with an ongoing total product life cycle activity that incorporates and continually considers risk management data, clinical data, post marketing surveillance data, etc. This highlights the need for manufacturers to regularly review and update their CER.
The first Appendix (A.1) discusses equivalence, and this will need to be much rigorously documented and reviewed, and also will be more critically reviewed by both Notified Bodies and Competent Authorities. This is of course also aligned with the concept of equivalence promulgated in the compromise MDR text.
Draft MDR and IVDR
As Methodize has also previously reported, regulators agreed to a compromised text of the new MDR and IVDR, which was previously published. While these texts are not the final First Reading documents (there will still need to be a formal vote), they provide manufacturers with a clearer idea of how the new regulations will impact their CE Marking certification and compliance.
The MDR will likely be applicable in late 2019 or early 2020 and the IVDR will likely apply in late 2021 or early 2022. Publication of the final regulations (“entry into force”) is expected in late 2016 or early 2017, and there will be a three-year transition period for the MDR and a five-year transition period for the IVDR (this of course depends on the particular enforcement of each of the specific Notified Bodies (NBs).
We look forward to more MDR and IVDR updates in the coming months. In the meantime, we encourage all industry to previous content within the Methodize webpage, which provides greater insight into the details of the compromise text.
While we do not yet have an IVDR White Paper available, Methodize’s website does offer a brief initial analysis of both the draft IVDR and MDR upon request.
We remain at your service at Methodize for all matters related to the Authorized Representative service.
[MDD and IVDR]
Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell) www.methodizeinc.com