This week’s Article 22 delineates the salient requirement that Member States must comply with this Directive. Compliance to Directives is not optional for the manufacturers of IVDDs and the same holds true for all 27 Member States. Isn’t life grand?
This edition of Devine Guidance provides guidance for the final two Articles associated with the Medical Device Directive. Article 22 mandates that Member States are required to comply with the MDD no later than 01 July 1994, and Article 23, while not addressed to device manufacturers, is addressed to Member States. Device manufacturers need to know that there are 23 Articles; however, in regards to Articles 22 and 23, they have zero influence on device manufacturers so please, just “forgetta-bout-it.”