Medical devices

French “Pilot phase” for the clinical investigation on medical devices

Eveline Van Keymeulen

In light of the upcoming entry into force of the EU Medical Devices Regulation ((EU) 2017/745) on 26 May 2020, France is the first EU country to prepare for its application in practice by means of a pilot project. The Regulation, amongst other things, sets out a revised framework for Ethics Committees and competent authorities Read More

Dutch Parliament agrees with amendment of Medicines Prices Act

Alex Crespo van de Kooij

On 2 July 2019, the Dutch Parliament voted in favour of a proposed amendment of the Medicines Prices Act. The amendment would result in Norway replacing Germany as one of the four reference countries for the maximum prices of medicines in the Netherlands. Belgium, France and the UK are the other three. The Medicines Prices Act Read More

Belgium amends procedure for notification of implants and certain invasive medical devices

Kaat Van Delm

On 1 June 2019, a new Royal Decree (dated 7 April 2019) altering the notification procedure for implants and certain invasive medical devices for long-term use entered into force. Previously, the Belgian Sickness and Invalidity Institute (RIZIV/INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical Read More

Belgium: Mobile health apps not yet reimbursable

Kaat Van Delm

An article dated 5 June 2019 in Belgian newspaper De Tijd has reported that owners of mobile health applications (mHealth apps) are currently waiting for the National Institute for Health and Disability Insurance (INAMI-RIZIV) to establish a procedure that will enable them to apply for reimbursement for patients who use their apps. The creation of such Read More

Belgium amends procedure for notification of implants and certain invasive medical devices

Kaat Van Delm

On 7 April 2019, a law altering the notification procedure for implants and certain invasive medical devices for long-term use was adopted. Previously, the Belgian Sickness and Invalidity Institute (INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical devices were required to register with the Read More