Medical devices

CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?

Eveline Van Keymeulen

In its judgment dated 7 December 2017 (Case C-329/16) the Court of Justice of the EU – rather unsurprisingly – confirmed that software which uses patient-specific data to aid prescription by detecting contra-indications, interactions with medicinal products and excessive doses falls within the definition of a medical device for the purposes of the Medical Devices Directive. Read More

Life Sciences IPOs – 5 things to consider

Michael Bloch

After spending all day last Wednesday at Biotech & Money’s IPO workshop presenting and talking to Life Sciences start ups about their IPO plans, we thought it might be interesting to bring together some of our key thoughts on IPO preparedness. Companies thinking about an IPO can never start planning too early.  IPO planning and Read More

Medical devices: European Commission updates Manual on Borderline Products

Eveline Van Keymeulen

The European Commission has issued a revised version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (Borderline Manual). The eighteenth version (1.18) of the Borderline Manual includes guidance on the classification of twelve additional types of products – 94 in total – including two new mobile applications. However, Read More

France: ANSM publishes Q&A for medical device manufacturers in case of notified body denotification

Eveline Van Keymeulen

The French National Agency for Medicines and Health Products Safety (ANSM) recently published a Q&A providing guidance for medical device and in vitro medical device manufacturers headquartered in France in case their notified bodies ceased operations, either voluntarily or following a denotification decision by the competent authority. The Q&A is particularly helpful in the absence Read More

Beyond the pill – are digital health deals set to spike?

Matthew Appleton

Transactions between big pharmaceutical companies and start-ups working on potentially highly disruptive but beneficial technologies in the healthcare space have not taken off as fast as some expected. That could be about to change. It probably wasn’t meant to take centre stage, but the small white circle on the arm of UK Prime Minister Theresa Read More