The EEC Council amended clause 114 of the Rules for registration and examination of the safety, quality and efficacy of medical devices: absence of a valid production inspection report in the dossier may now lead to suspension of the registration certificate. The change takes effect 30 calendar days after official publication. Source: Eurasian Economic Commission (EEC).
The aim is to keep manufacturers’ quality management systems up to date for medical devices placed on the Union market.
The new ground does not apply to non-sterile devices of potential risk classes 1 and 2a, for which a quality management system is not mandatory.