Medical devices

Germany: Reimbursement of Digital Health Apps – A “World First”

Eda Zhuleku

The Digital Healthcare Act (Digitale-Versorgung-Gesetz DVG) was published in the German Federal Law Gazette (Bundesgesetzblatt) on 18 December 2019 and entered into force on 19 December 2019, having been passed by the German Parliament (Bundestag) in November 2019. Among other regulations intended to expand the digitalisation of the healthcare system, the law will allow the Read More

Life Sciences and healthcare growth in more challenging times

Matthew Appleton

At a time of heightened regulatory and market uncertainty, it’s perhaps surprising to see life sciences and healthcare sector M&A continuing to grow so strongly. Indeed, with deal value up by more than 19%, it was one of only two sectors to record growth in transaction value. Not surprisingly, given the scale of the U.S. Read More

Europe: Medical Devices Coordination Group issues guidance on the classification of software as a medical device

Jacqueline Bore

The Medical Devices Regulation, the “MDR”, which comes largely into force in May 2020, will introduce significant changes to the way in which software used in a medical context will be regulated in the European Union. The medical devices industry has been eagerly awaiting additional guidance on how these new provisions are likely to be Read More

Slovak parliament rejects draft law which would soften regulation of CBD (cannabidiol)

Zuzana Hecko

In August 2019, the Slovak government introduced a draft law which suggested removing CBD (cannabidiol) from the list of psychotropic substances. The draft law therefore attempted to make CBD a non-regulated substance. The draft law was, however, subsequently rejected by the Slovak parliament. Act No. 139/1998 Coll. (the  Narcotics Act) places CBD in the same Read More

New EU Directive on Whistleblower Protection will also apply to Life Sciences sector

Inge Vanderreken

On 7 October 2019, the Council of Ministers adopted the Directive on Whistleblower protection at the Justice and Home Affairs Council in Luxembourg. The Directive will introduce new EU-wide rules to protect whistleblowers who report breaches of EU law. “EU law breaches” include, amongst others, those relating to EU laws on product safety and compliance, Read More