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Posts Tagged ‘medical devices’

Healthcare Transparency Register concept law

May 14, 2019

The Netherlands 

On 30 April 2019, the concept text for the Healthcare Transparency Register law was presented for consultation. With this concept law, the obligation for suppliers of medicines and medical devices to report financial relationships with healthcare professionals and patient organizations to the Healthcare Transparency Register becomes legally anchored.  

The concept law anticipates the evaluation of the Healthcare Transparency Register that is currently being carried out by the Institute for Rational Use of Medicine. The results of this evaluation are expected by the end of this summer. 

The Healthcare Transparency Register Foundation will study the concept law and involve it in the results of the evaluation.

Source 

Autocontrol and ‘only once-principle’

February 6, 2018

Belgium

The Royal Decree of 15 November 2017 regarding the notification of a materiovigilance contact point and the registration of distributors and manufacturers of medical devices concerns the introduction of a new registration procedure that should limit the administrative burden following the ‘only once-principle’. So, the aim is to collect all information that is already known within the authorities (KBO/BCE, VAT databank).

Practical consequences?

  • ABGD/SADN application will be replaced by a new web portal
  • Manufacturers and importers will no longer be encoded by the system as ‘distributor’ but instead according to their exact activity

Additionally, new rules are laid down in this Royal Decree concerning market surveillance of medical devices.

Guide on Medical Devices Regulations

February 5, 2018

The Netherlands

The European Regulation for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) will fully apply in 2020 and 2022, respectively. This new regulation will have consequences for the marketing authorization of medical devices.

The ministry of Health, Welfare and Sport (VWS) together with the Inspection and the Dutch National Institute for Public Health and the Environment (RIVM) developed a guide to help all parties prepare for 2020 and 2022. This guide includes the most important changes that come together with these new regulations and can be consulted here.

Ban on inducements in the Dutch medical device industry

September 20, 2017

CGR

Earlier this year in the Netherlands, the Medical Devices Act has been adapted thereby introducing a ban on inducements that are aimed at stimulating the prescription or supply of medical devices. Details on this policy have been published by the Dutch Foundation for the Code for Pharmaceutical Advertising (CGR) and can be found in their newsletter.
Similar to the Medicines Act, inducements for medical devices are also forbidden, except for following exemptions:

  • Sponsoring is permitted when it complies with certain conditions.
  • Contributions to costs related to meetings and events is allowed. However, understanding of the words ‘meetings’ and ‘events’ in case of medical devices is slightly different from those described in the law on medicines.
  • Fee for services can be granted similarly as in the scope of medicines.
  • Gifts are permitted with a maximum of €50 per gift and €150 per year per supplier (but not per therapeutic classification).
  • Reductions and bonuses can be offered. Additional conditions are included in the policy.

The Medical Devices Act and this policy enter into force on 1 January 2018. The Dutch Ministry of Public Health (VWS) has announced its intention to adapt the policy for medicinal products as well, which will likely be adapted and aligned with the policy for medical devices. Which implicates that also for the specific conditions for sponsoring are to be expected.