Medical devices

New measures on advertising and information of health products take effect in France

Eveline Van Keymeulen

In October 2018, Decree No. 2018-864 on the presentation, information and promotion of health products and related services entered into force, which was adopted pursuant to Article 58 of the Social Security Financing Bill. The decree introduces measures that aim to provide quality information to assist healthcare professionals in their therapeutic choices for health products, Read More

CJEU confirms that prior authorisation for a drug-incorporating device is not an MA under the SPC Regulation

Michael Krenz

The Court of Justice of the European Union (CJEU) has ruled that a supplementary protection certificate (SPC) cannot be granted for a medical device comprising an active ingredient because the EU authorisation procedure for devices does not result in a marketing authorisation (MA). The request was made in proceedings brought by Boston Scientific Ltd. and Read More

Belgium: Mobile health apps can now be published on mhealthbelgium.be

Kaat Van Delm

From the end of October 2018 onwards, companies can apply for publication of their mobile health-applications (mhealth apps) on the governmental website “mhealthbelgium.be“. The website aims to encourage mobile health and make mhealth patient care an integrated pillar of the healthcare sector. It has been created through cooperation among Belgian authorities for food, medicines and Read More

European Commission’s proposal for a Regulation on Health Technology Assessment clears another hurdle

Jacqueline Bore

The European Parliament has adopted the legislative report of its committees on the European Commission’s proposal for a Regulation mandating joint health technology clinical assessments of medicinal products and medical devices. The aim of the proposal is to promote co-operation at EU level in assessing the added benefits of new health technologies, with the aim that Read More

Dutch authorities to investigate possible inducement payments in medical devices sector

Iradj Nazaryar

The Dutch Health and Youth Inspectorate (HYI) has announced plans to investigate possible inducement payments in the medical devices sector. The investigation, which will start in the autumn of 2018, will focus on cardiology, orthopaedics and dental implants by looking into the service contract meetings that suppliers may have concluded with healthcare professionals. Moreover, suppliers Read More