BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow
Executive Summary
There is not much demand currently for testing against the EU's Medical Devices Regulation (MDR). But demand for certificate renewal under the current medical device directives is very high. What does all this mean as the EU attempts to introduce tighter requirements for medical devices?
You may also be interested in...
MTI Outlook 2020: Medtechs Enter The Decade Of Digital, Consumers and Wellness
For health-care providers and medtech manufacturers alike, the decade ahead will require a coming to terms with digital technologies and integrating new methods of payment. Quality of service delivery remains the market-entry criterion, but companies will have to adapt to evolving health-care models. The stakes are high. Will manufacturers be able to capitalize on the changes in a market that is more competitive and unpredictable than ever?
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.