Long-Awaited EU IVD Classification Guidance Just Published: Initial Reactions
The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-four guidance documents have been posted on the tracker since its last update.
It is just over 18 months until the full application of the IVD Regulation. The MDR may be the main focus of attention, but there is no less urgency when it comes to preparing for the IVDR. But the industry is dragging its feet.
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.