October 15, 2019

[FEATURED] Cost Of Certification Under IVDR Is Going To Be Huge As Manufacturers Battle Hurdles

There has been no recent impact assessment as to how business will be affected by the text of the IVD Regulation that was finally adopted. Consultant Robyn Meurant explains how industry will be paying a high price, and why many IVD companies could go under.

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October 3, 2019

[FEATURED] Regulators Urged To Avoid ‘Conflicting’ Clinical Requirements For Drug-Device Combinations In EU

EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that will kick in soon for integral drug-device combination products.

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September 25, 2019

[FEATURED] It Is A Great Time to Move Within Regulatory – Especially If You Know What To Expect

The demand to fill EU regulatory roles is at its peak and is dictating the very nature of employment in the medtech sector. Amanda Maxwell spoke with recruitment expert Elena Kyria to hear her views on how to maximize the unique opportunities that currently exist. This is Part 1 of a three-part interview series on recruitment in medtech. 

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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.

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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.

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