With Brexit less than a month old, Germany’s medtech industry has renewed its push for an MRA between the EU and UK in medtech regulation.
Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions have brought their plans to a halt. The EU is trying to break the impasse.
The European Commission’s output of guidance documents over the last few months has been extraordinary, and unprecedented. A new website gives users access to all these documents and shows what has changed.
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.
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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