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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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News

Regulation of COVID-19 Tests in the EU: when do you need to involve a Notified Body?

Since early this year, the COVID-19 virus substantially affects our daily life. Testing for the presence of or past exposure to the virus is an essential aspect of combatting the COVID-19...

News

FDA finalizes policy on multi-function medical devices’ premarket submissions

On July 28, the U.S. Food and Drug Administration (FDA) issued the final guidance “Multiple Function Device Products: Policy and Considerations,” which describes FDA's...

News

COVID-19- AFMPS reviews its export ban on certain medicinal products outside the EEA

The Belgian federal agency for medicines and health products (AFMPS or FAGG) provides that Belgium acts as a logistical platform for certain medicinal products. The ban on export of...

News

Belgium follows the FDA's approach on the reprocessing of surgical masks and FFP2/FFP3 facemasks

Given the challenges in maintaining the supplies of health care materials such as surgical masks and FFP2 and FFP3 face masks, the Belgian Task Force on shortages, a working group set up by ...

News

New European Commission's guidance document on medical devices and IVDs in the COVID-19 context

On 3 April 2020, the European Commission issued a guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices ("IVD") in the COVID-19...

News

EU suspends tariffs on medical equipment

Following requests from numerous Member States, on 3 April the European Commission (“Commission“) adopted Commission Decision (EU) 2020/491 (“the Decision“), which ...

Hogan Lovells Publications

The EU and various member states measures on Personal Protective Equipment in response to the COVID-19 outbreak

In response to the global outbreak of the COVID-19 virus, the EU and various member states have taken measures to ensure continuity of supply of personal protective equipment (PPE) and...

News

European Commission announced its plan to postpone the implementation of the MDR by one year

The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement...

News

Belgian AFMPS latest guidance in the context of COVID-19 outbreak
Registered Content

The Belgian Federal Agency for Medicines and Health Products (AFMPS) released a series of guidance and recommendations over the last few days in relation to the COVID-19 outbreak. They...

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