Upon request by the European Commission, a survey intended for economic operators is ongoing to monitor and analyse the availability of medical devices on the EU market in the context of the implementation of European Regulations 2017/745 (MDR) and 2017/746 (IVDR). This survey aims to identify obstacles that could affect availability of devices and/or impair the conformity assessment process, pointing to potential solutions.
News FAMHP
There are 56 result(s) found based on your search criteria
1-10 from 56 result(s)
Evaluation of European regulations on medical devices: the European Commission launches a public consultation
The European Commission has launched a public consultation to assess Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) on medical devices and in vitro diagnostic medical devices. The aim of this initiative is to gather stakeholders' opinions on the effectiveness of the current regulations and to identify any shortcomings.
Obligation for manufacturers to notify interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices
From 10 January 2025, manufacturers will have to report interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices placed on the European Union market for which it is reasonably foreseeable that such absence from the European market could endanger patient or public health in one or more countries.
Publication of a guidance for the implementation of a self-checking system related to the installation and maintenance of medical devices used in the diagnosis and treatment of sleep apnea syndrome outside the hospital
Pursuant to the Royal Decree of 24 October 2024, the FAMHP has approved a guide explaining in detail all the aspects that actors in the service and technical home assistance (STHA) sector must take into account to correctly set up a self-checking system. This guide includes a set of obligations.
Notification procedure for advertising of medicinal products for veterinary use to the public
On 1 January 2025, the Royal Decree of 22 September 2024 on advertising of medicinal products for veterinary use will come into force. That Decree describes the mandatory notification procedure prior to the distribution of any advertisement for a medicinal product for veterinary use to the general public.
Call to professionals responsible for materiovigilance: take part in European Commission survey on electronic instructions for use
The European Commission is considering allowing the use of electronic instructions for use for all devices for professional use. The Commission is therefore launching a survey for healthcare professionals.
Improving the availability of in vitro diagnostics: European measures
New measures published in the European Union’s Official Journal come into effect to improve the availability of in vitro diagnostics, for patients and healthcare providers.
New system for financing the surveillance of the medical devices market
A new system for financing the surveillance of the medical devices market applies from 2023. This system aims to make fees fairer between the different stakeholders in the sector, as each one must pay a fee that is consistent with its turnover and with the level of risk involved in its activity and in the workload it represents for the FAMHP.
End of the validation procedure for SARS-CoV-2 antigen self-tests
The validation procedure for SARS-CoV-2 antigen self-tests with a CE-marking ceased to apply since 23 January 2023. The associated list of recommended SARS-CoV-2 antigen self-tests with a CE-marking is therefore no longer available.
Call for Belgian laboratories to apply to become the European Union reference laboratory for in vitro diagnostic medical devices
The European Commission has launched a call for laboratories of Member States to apply to become European Union reference laboratories (EURLs) for in vitro diagnostic (IVD) medical devices. The possible designation of such EURLs is provided for in article 100 of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).