Medical devices

New Belgian life sciences regulations on pricing and clinical trials published

Tine Carmeliet

Two new Belgian regulations relevant to life sciences stakeholders were published in the Belgian Official Journal on 31 December 2018. A Ministerial Decree adopted on 21 December 2018 has amended the Ministerial Decree of 17 June 2014, which sets the maximum prices for medical implants, refundable and non-refundable medicines, generic medicines and medicines that are imported Read More

French State held liable in PIP case

Eveline Van Keymeulen

On 29 January 2019, in an instance brought by a victim in the infamous case of defective (Poly Implant Proth√®se) PIP breast implants, the Administrative Court of Montreuil held the French State liable, considering that AFSSAPS, the predecessor of the current National Agency for Medicines and Health Products Safety (ANSM), did not “take the necessary Read More

MHRA provides further guidance on no-deal Brexit plans

Jacqueline Bore

The MHRA has issued updated guidance on its plans for the regulation of medicines, medical devices and clinical trials in the event that the United Kingdom leaves the European Union on 29 March 2019 without any agreement on its future relationship with the EU and, therefore, without any transitional period. The guidance reflects responses to Read More

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