The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device Regulation. The proposal will now be negotiated by the European Parliament and the Council.
The FDA has granted several exemptions to its Medical Device Reporting requirements related to events identified in certain real-world data sources, such as medical device registries.
Cybersecurity, remanufacturing of devices and chemical analysis for biocompatibility assessment of medical devices are among the topics FDA plans to address through draft and final guidances in 2023.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.
A discussion of the changing medtech markets and how companies can remain cognizant of potentially disruptive changes in their business and industry for future success in their product portfolios, services and relationships.
The outlook for 2020 and beyond is positive, but medical device companies must continue to evolve their technologies and partnerships to keep the attention of investors.
