ARTICLE SUMMARY:
In this week’s roundup: The European Commission launches a new study to assess MDR/IVDR implementation; smaller firms dominate the first round of EU “scientific advice” pilot; industry is set for the first EU HTA stakeholder group meeting; US debt deal could pressure FDA, and an eye on device shortage and labeling legislation in Congress; FDA seeks input on home-based tech; Medicare contractors target genetic testing; and more on CPT codes, EPA, and UK NICE.
EU Picks
Actions on MDR and HTA:
EU reassesses regulations. The European Commission is launching an 18-month study to assess “innovation” in governance of the Medical Device and IVD Regulations. It is starting to collect input from national competent authorities at this week’s (June 6-7) Medical Device Coordination Group meeting in Brussels, and will follow-up after the summer to engage notified bodies and industry. For more details, see “EU Interrogates MDR/IVDR Strengths and Shortfalls.”
Scientific advice for SMEs. Another topic of focus at this week’s MDCG gathering will be the European Medicines Agency pilot program offering expert panel scientific advice for planning MDR clinical investigations for select firms. So far, the program seems to be attracting interest principally from smaller firms, according to data presented by an EMA official last week at The MedTech Forum in Dublin. For more, see “EMA Attracts Mostly Small Companies to MDR “Advice” Pilot.”
