By Marcelo Trevino, Applied Medical
As we move towards the E.U.’s Medical Device Regulations (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746) — MDR and IVDR, respectively — the technical committees are in the process of determining necessary changes to the European Harmonized standards, including the incorporation of the new Annex ZA/ZZ.
The harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. Although technical committees can start drafting changes, the European Commission must issue official standardization requests, which hasn’t occurred yet. The European Commission defines the items needing standardization, and must review each revised standard against the General Safety & Performance Requirements before it can officially recognize a standard. To accomplish this, the European Commission considered splitting the Standardization Requests and consulted with all relevant technical committees to include key standards, but then realized that splitting the standards would result in a very slow process.
While this process will probably take the European Commission a long time to complete,…
