September 12, 2019

[FEATURED] Global Call To Rethink MDR Timing Sees Commission Dig Heels In Further

The calls for a delay in the implementation of the new EU MDR are becoming increasingly loud on the international front, with the US, for one, wanting to see a three-year postponement. Is the European Commission right to remain stubbornly attached to its deadline?

Do you like it?0
August 29, 2019

[FEATURED] EU MDR: Handful Of Additional Notified Body Designations Await Go-Ahead

Recent indications from the European Commission led EU medtech stakeholders to believe that more notified bodies would have been designated by now. Not so, and the lack of any visible progress means that, for manufacturers, nerves will start to jangle again before long.

Do you like it?0
August 20, 2019

[FEATURED] Commission’s Latest Stats Show How 10 MDR/IVDR Notified Bodies By Q3 2019 Is Now Possible

The European Commission’s latest figures indicate that at least 20 notified bodies will be designated by 26 May 2020 – the date by which the new medical device regulation will become fully applicable. But is there still enough time?

Do you like it?0
August 7, 2019

[FEATURED] Two More Notified Bodies About To Be Designated And Surge In Publications Of New Documents

The European Commission came under a great deal of pressure in June to deliver the fundamental structures and documents needed for implementing the EU’s new medtech regulations. It has hit the ground running so far this month.

Do you like it?0
July 25, 2019

[FEATURED] Brexit Delay Gives EU27 Yet More Time To Grow Number Of EU-Compliant Devices

Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?

Do you like it?0

RAPS Regulatory Convergence 2019

September 21-24, 2019 in Philadelphia, PA

Interested in discussing regulatory or medical writing projects? President Laurie Mitchell and CEO Lalitha Jonnavithula will be taking meetings at booth #439 at RAPS 2019.

Book a consultation with us for exclusive tips, assets and more. Stop by the booth and sign up for the chance to win a FREE Amazon Echo!