February 4, 2019

[FEATURED] Complying On Time With MDR/IVDR: What Options Are Open To Those In Trouble?

Manufacturers who have not managed to transfer their certificates from a UK notified body prior to Brexit, or who have not obtained certificates under the EU Medical Device or IVD Regulations in time, can not expect to receive a sympathetic hearing from the EU Commission. In an interview with Medtech Insight, Lawyer Alison Dennis examines options for medtech firms.

Do you like it?0
January 23, 2019

[FEATURED] Two EU Notified Body Frontrunners In Race For Designation Under New Regulations

The latest revelations in London and Brussels over the last week show concrete progress is being made toward the designation of notified bodies. But which organizations will be named first and when?

Do you like it?0
December 30, 2018

[FEATURED] When Will EU Commission, Member States React To Calls For Extending Regulation Deadlines?

The EU medtech sector, seeing itself heading for a crisis, is hoping the authorities will imminently extend deadlines for the Medical Device and IVD Regulations. What more do we know after last week’s crucial Medical Device Coordination Group meeting?

Do you like it?0