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European Medical Device Regulation (MDR)

Mark Cusworth, PRISYM ID, examines EU Medical Device Regulation and its implications on labeling – and looks ahead to a Christmas future that could become a nightmare unless companies act now. more

17 Nov 2017 10:38 Features

Sheena Linehan, patent attorney at IP law firm Potter Clarkson talks about the new EU medical devices regulations and why IP strategy needs refreshing. more

13 Nov 2017 09:05

The BSI’s UK & Ireland Medical Devices Regulatory Seminars in November are for all medical device manufacturers, regulatory affairs and quality assurance staff. more

23 Oct 2017 15:37 News

Global public health and safety organisation NSF International recently completed the acquisition of Prosystem, a German medical device consulting firm specialising in regulatory affairs and clinical evaluation. more

10 Oct 2017 09:45 News

The British Standards Institution (BSI) tells Med-Tech Innovation why it developed Compliance Navigator – a workflow tool that takes the leg-work out of managing medical compliance. more

4 Oct 2017 13:57 Features

Here’s ten things you really need to know about the new European Medical Device Regulation. more

29 Sep 2017 10:19 News

An introductory guide has been made available by the Medicine and Healthcare products Regulatory Agency (MHRA), so manufacturers are aware of requirements under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR). more

30 Aug 2017 16:30 News

Now in its 15th year, the Medtec Ireland trade show will be exploring recent advancements in medical devices. more

7 Aug 2017 15:39 News

Quality provider InfinityQS has argued that the medical device industry must develop a common language within its data systems to ensure full legal compliance and internal traceability. more

27 Jun 2017 10:45 News

Paul Brooks, Regulatory Affairs Professionals Society (RAPS), discusses the impact of European Medical Device Regulation on currently marketed medical devices and offers guidance for manufacturers. more

15 Jun 2017 14:35 News

Maetrics reveals the practical implications for medical device manufacturers and how to address them as the new MDR comes into force. more

1 Jun 2017 12:13 News