Medical devices

CJEU confirms that trade mark owners need not amend broad specifications

David Stone

Today, the Court of Justice of the EU (CJEU) in Sky v SkyKick (C-371/18) has declined to follow the Advocate General and held that trade mark specifications that cover broad terms such as “computer software” cannot be invalidated on the basis that they are imprecise or contrary to public policy. In addition, a trade mark Read More

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

Belgium: New nomenclature for incidents with medical devices

Kaat Van Delm

A group of the International Medical Device Regulators Forum (IMDRF) has recently developed a new nomenclature for the reporting of incidents with medical devices, which will become applicable in 2020. The newly introduced codes will be used primarily to complete medical device reports (MDRs). They will therefore already form part of the new incident report 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