The European Commission has published a new draft standardisation request, asking the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) to revise the existing harmonized standards and to draft new standards to cover specific areas of both Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVDs) under the new regulations.
Interestingly, this new request includes way more standards to revise and draft than the previous request (performed earlier this year, in May), which was rejected by the CEN and the Cenelec. However, unlike in the previous request, where certain deadlines for the review of some standards were set for 2021 or 2022, all deadlines have been extended until July 2024. Thus, would this draft be approved, a specific date for the harmonization according to MDR/IVDR would be set.
If you have any questions do not hesitate to contact us at: email@example.com