Delayed Implementing Regulation On Annex XVI Common Specifications Finally Adopted
While delays with aspects of the implementation of the Medical Device Regulation are all too familiar, threat of action at European Court of Justice level is unprecedented. But such measures have paid off for manufacturers of non-medical devices.
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Reclassification Of Active Annex XVI Products Now Official
Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.
Commission’s Rolling Plan Dwindles To Three Key Items, Including Eudamed
There is a clear need still to harness a better strategy for fully implementing the Medical Device and IVD Regulations; but the good news is that most items on one key list have now been completed.
Annex XVI Manufacturers Send Formal Notice To Tardy European Commission
Lawyer applauds “courageous reaction” of manufacturers of devices without an intended medical purpose which fall under Annex XVI to the Medical Device Regulation and whose products are threatened by the delays in the publication of common specifications.