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Posts Tagged ‘medical device’

Liberalization of the Belgian Distribution Channel for Medical Devices: a New Royal Decree

January 29, 2019

Belgium

On 28 January 2019, the new Royal Decree of 19 DECEMBER 2018 on the liberalization of the distribution channel for medical devices has been published in the Belgian Official Gazette. The new Royal Decree will come into force on 7 February 2019.

The most important changes imply that, as of 7 February 2019, the Belgian distribution channel for Medical Devices and Active Implantable Medical Devices is no longer restricted to (hospital) pharmacies. From that date, patients and healthcare professionals can purchase medical devices, such as sterile bandages or physiological serum, directly from any distributor, from pharmacy to supermarket, and even directly from the manufacturer. The distribution of medical devices will also be facilitated for laboratories, nursing homes and private clinics.  This liberalization should ensure that the access of end-users and patients to medical devices is better aligned with the principles of free movement of products with CE Marking within Europe. Nevertheless, the liberalization shall have no impact on the safety or efficacy of the medical devices on the Belgian market and does not affect the reimbursement conditions set by the RIZIV/INAMI.

In Belgium, all distributors and exporters must be registered with the FAMHP. For manufacturers, there is currently no direct obligation to register.

More information can be found here.

 

New Medical Device Directive

April 14, 2017

EU

Finally some progress! The final versions of the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, resp.) have finally been approved by the European Parliament on April 5th 2017. Formal publication of the MDR and IVDR in the Official Journal of the European Union is anticipated for early May 2017. Twenty days from that publication, likely in early June 2017, the Regulations will enter into force. Accordingly, the MDR will probably be applicable by 2020 and the IVDR by 2022.