the European Union Commission published two new measures aimed at improving the safety of medical devices.
In September 2013, the European Union Commission published two new measures aimed at improving the safety of medical devices. One of these measures – recommendation 2013/473/EU – published on the 24th of September 2013, included a requirement in Annex III for notified bodies, including LRQA, to complete unannounced visits.
Questions about the new requirements? LRQA is your resource for Medical Directives audit regulation and guidance. We encourage you to review the following information from Martin Penver, LRQA Operations and Technical Manager – Medical Device.
Medical Device Client Information Note: Unannounced visits – recommendation 2013/473/EU
2013/473/EU Unannounced Pre-Visit Questionnaire : Complete this questionnaire by March 30, 2014 to help ensure your unannounced visits are effective
LRQA Unannounced Visits Webinar: Understanding what’s required of medical device companies
Contact us to learn more about In Vitro Diagnostic Device Regulation (IVDR)