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Medical Devices - Regulatory Updates - September Vol. 2

September 17, 2020 Regulatory Updates

The UK has left the EU, and the transition period after Brexit comes to an end this year. Stakeholders need to get ready for new rules from 1 January 2021.

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Medical Devices - Regulatory Updates - September Vol. 1

September 03, 2020 Regulatory Updates

As of 1 September 2020, all medical devices used by care providers must have a CE marking. Since mid-March, due to shortages caused by the corona pandemic.

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Medical Devices - Regulatory Updates - August Volume 2

August 19, 2020 Regulatory Updates

In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September.

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Medical Devices - Regulatory Updates - August Volume 1

August 04, 2020 Regulatory Updates

The European Commission has published an overview of the information that will be publicly available under EP and Council Regulation (EU) 2017/745 on medical devices.

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Medical Devices - Regulatory Updates - July Volume 2

July 16, 2020 Regulatory Updates

On the 9th of July 2020 the European Commission has adopted a Communication to help national authorities, businesses and citizens prepare for the inevitable changes.

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Medical Devices - Regulatory Updates - July Volume 1

July 02, 2020 Regulatory Updates

Due to the corona crisis the majority of the clinical trials conducted were put on hold. Since the Dutch Government currently gradually reduces the restrictive measures.

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Medical Devices - Regulatory Updates - June Volume 2

June 17, 2020 Regulatory Updates

The European Commission’s Medical Device Coordination Group (MDCG) issued guidance explaining the process for transitioning CE certificates

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Medical Devices - Regulatory Updates - June Volume 1

June 3, 2020 Regulatory Updates

The AEMPS extends the deadline until May 25, 2021 for the adequacy of the labeling and the instructions for use of medical devices as a consequence of the changes made by Brexit

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