In this week’s roundup: EU policymakers build pressure on industry to comply with the Medical Device Regulation as soon as possible; senators advance FDA legislation but show a growing partisan split; some medtech amendments to the moving user fee legislation address device modifications, export certificates, and waived registration fees; new leadership at the Medical Device Innovation Consortium, CPT panel updates, and more.
EU escalates MDR rhetoric:
Don’t expect the EU government to bail your company out if it hasn’t transitioned all of its devices to the Medical Device Regulation by 2024, the European Commission’s Medical Device Coordination Group (MDCG) warns in a position paper. Soon after national European competent authorities expressed urgency about MDR challenges, MDCG says device firms need to take responsibility for getting quality, complete MDR applications in to notified bodies ASAP or risk noncompliance. Read more: “EU Commission Ratchets Up Pressure on Companies to Expedite MDR Compliance,” Market Pathways, June 14, 2022.)