Arthur Cox is pleased to present the first of a series of knowledge bites to prepare medical device manufacturers for the new EU medical device regulations, otherwise known as the Medical Device Regulation ("MDR") and the In Vitro Diagnostic Regulation ("IVDR") (both referred to as the "Regulations".)
We all know that notified bodies will have a bigger role to play in the enforcement of the new MDR and IVDR which also brings greater scrutiny over these bodies. One of these roles is the right to carry out unannounced on-site audits and to conduct physical or laboratory tests on medical devices as part of their compliance activities.
While some notified bodies have already begun unannounced audits following Commission Recommendation 2013/473/EU, the new Regulations will now make this a binding obligation on all notified bodies. Occurrence of unannounced audits is about to grow as unannounced audits will now apply to manufacturers of certain devices, including self-certified IVDs, that did not previously require the involvement of a notified body.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.