ARTICLE SUMMARY:
A revised request is finally in to harmonize hundreds of standards to the EU MDR and IVDR after a first attempt was rejected last year, and guidance was issued to help companies leverage standards to comply with the new rules.
The European Commission followed through on its planned second stab at getting technical device standards harmonized to support the new EU Medical Device and IVD Regulations. On April 15, it submitted a revised Implementing Decision to the EU standards organizations European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC).
