MEDIcept Insights
Seeing Red (And Yellow): Notified Body BSI’s ‘Scorecard’ Shows Plenty Of Work Needed To Meet E.U.’s 19-Point MDR/IVDR Compliance Plan (1 Of 2)
The Medical Device Coordination Group released in August a 19-point action plan that the MDCG says will make sure medical products can be certified to the E.U.’s new MDR and IVDR regulations within prescribed transition time frames. The Position Paper, MDCG 2022-14,...
Gimme ‘MORE’: U.K.’s MHRA Wants Adverse Events From Device Makers Via ‘New’ MORE Portal
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on Oct. 6 told medical device manufacturers that beginning next month they must send post-market vigilance reports via the MHRA’s “new” Manufacturer's On-line Reporting Environment (MORE) portal. As...
Kiss Your CDs And Thumb Drives Goodbye: FDA Will Accept Only Electronic 510(k) Submissions Next Year
Makers of medical devices will have to submit 510(k)s to the Food and Drug Administration electronically beginning in October 2023, a new guidance document from the U.S. agency says. Through the 16-page guidance dated Sept. 22, manufacturers are being forcibly nudged...
Combo Drug/Device Products: FDA Notice Aims To Reduce Manufacturer Burden
Manufacturers have been given direction by the U.S. Food and Drug Administration on how they can best comply with the agency’s current good manufacturing practice (CGMP) requirements for combination drug/device products. In a Final Notice published in the Federal...
Risky Business: FDA Trots Out Risk-Based Framework For Validating Software For Quality Systems, Device Production
Manufacturers would apply a risk-based approach to validating software used in quality systems and the production of medical devices under a new proposed guidance document from the U.S. Food and Drug Administration (FDA). Dated Sept. 13, the 25-page draft doc,...
New FDA Guidance Doc Lays Bare Process For Requesting EUAs For Monkeypox Diagnostics
The Food and Drug Administration (FDA) says in a Sept. 7 guidance document that it’s offering templates for diagnostics developers to use as they seek Emergency Use Authorization (EUA) from the U.S. agency for monkeypox diagnostic tests. The templates, which offer...