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EU Regulatory Update | News on the EMA expert panel and more

As of the first of March, the coordination on the expert panel has shifted from the Joint Research Centre in Italy to the pharmaceutical agency EMA in Amsterdam.

Europe IVDR MDR 2017/745 Notified Body

EU Regulatory Update | MDR extension – the hot debate

If one thing is debated in the Brussels MedTech corridor, it is the path forward out of the resource and time crunch to get all products certified under MDR and IVDR.

In-Vitro Diagnostics Medical Device Regulations

EU Regulatory Update | The Slovenian Institute of Quality and Metrology (SIQ) designated as an MDR Notified Body

The Slovenian Institute of Quality and Metrology (SIQ) was designated as a Notified Body under Regulation (EU) 2017/745 (MDR).

MDR 2017/745 Medical Device Regulations Notified Body

EU Regulatory Update | Detailed and clear policy on Dutch Authority intervention MDR/IVDR

The document describes the policy on healthcare supervision, and explains how it moves away from the old thinking into the new era of MDR and IVDR.

Europe IVDR Medical Device Regulations Regulatory Compliance

EU Regulatory Update | What is the difference between the European Union and the Union, and why does it matter for IVDR?

When applying the requirements of the IVDR, manufacturers should ensure that they are applying these for products and services supplied to laboratories and patients in countries within the Union (EEA) and not just those that are part of the EU.

Europe In-Vitro Diagnostics IVDR

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