ARTICLE SUMMARY:
EU guidance group puts industry on notice about slow or incomplete Medical Device Regulation compliance efforts. National competent authorities are also stepping up urgency, although they more directly acknowledge the “shared responsibility” to contend with MDR challenges.
The European Commission’s guidance-setting arm fired shots across the bow to companies that aren’t moving as quickly as possible to fully comply with the Medical Device Regulation. In a “position paper” issued June 13, the EU Medical Device Coordination Group (MDCG) made it clear that companies shouldn’t expect additional flexibility if they aren’t ready to properly operate under the MDR by 2024.
