EU MDR Compliance Isn't Automatic For Legacy Devices, So Plan Ahead, Says RAPS Director
Executive Summary
What can companies that currently have products on the EU market do to optimize their regulatory strategies under the new Medical Devices Regulation, and how can they navigate the hazards. Paul Brooks, who heads the Regulatory Affairs Professionals Society and spent years at a notified body, weighs in.
You may also be interested in...
MDR/IVDR Survey: Most Manufacturers Ready To Yank Some Legacy Products From EU Market; Hiring Up At Firms
The impending implementation of the EU's new Medical Device and IVD Regulations will cause most firms to pull select legacy devices and in vitro diagnostics from the EU market, a survey of 169 quality and/or regulatory professionals finds. The survey also revealed that companies are in hiring mode as the compliance dates for both regulations approach. Quality and regulatory officials from Abbott Laboratories and Meridian Bioscience weigh in.
EU's New Medical Device Regulation: A Timetable To Kickstart Planning
The EU's Medical Device and IVD Regulations are published in the Official Journal of the European Union, setting a series of deadlines for implementation and compliance. There is a lot to do in a relatively short amount of time. Here's a timetable of what to expect.
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.