In Belgium, medical device operators will no longer be able to carry out their activities from June 17 unless they have complied with relevant registration requirements and registered with a new web portal by that date.
The new rules apply to manufacturers, authorized representatives, distributors, exporters and importers to differing extents, and are quite complex.
The new registration procedure has been implemented for all operators in the sector based on the "once only" principle of administrative simplification, which provides that a citizen has to provide the authorities with the same information only once.
Follow The Flow Charts
There are a series of flow charts of varying complexity on an FAQ website indicating whohas toregister, and who is invited to register.
In the case of manufacturers, the new rules are intended to ensure full capture of information concerning the following products that enter the Belgian market through a Belgian-registered office (where notified bodies are not involved):class I; custom-made; systems and procedure packs or IVDs.
They are also intended to capture information about the full range of medical device products placed on the market in Belgium, where a Belgian registered office is not involved.
Registration will be free of charge and, according to the Belgian website, should be in French or Dutch. However, a spokesperson for the Belgian Federal Agency for Medicines and Health Products, AFMPS, toldMedtech Insight that German and English are also accepted.
The agency says that the registration applications are currently only available for operators based in the EU. But the system is in the process of being revised so that operators based in a third country (outside the EU) can access them.
The authorities say this tool will be able to gather a maximum amount of information already known to other authorities/bodies, such as the data encoded in the Crossroads Bank for Enterprises (CBE – aregister that stores all basic data regarding enterprises and their individual business locations) or in the European VAT number database (VIES), pending launch of the EU MDR-Eudamed database.
How It Works In Practice
For registration purposes, Belgian authorities have made available a new web portal including four applications:
- My enterprise: An application covering general information on the business.
- My activity: An application covering activities such as manufacturing, distribution, exportation and also the risk classes of the medical devices concerned under the current medical device directives (class I, IIa, IVD list A, IVD list B).
- My control: An application covering forms (used for risk analysis) and offering a platform for communication relating to the inspections performed by our inspection services.
- My address book: An application used by distributors to provide information on the names of the manufacturers and authorized representatives of the devices that they distribute.
The agency is developing other applications, which it intends to release later in 2018 and 2019. These will cover:
- My medical devices: Covering information on the medical devices that are manufactured and distributed.
- My export certificates: To be used to submit export certificate applications.
- My manufacturers: To be used by authorized representatives to provide complete information on manufacturers outside the EU that they represent.
The AFMPS spokesperson explained that, for the moment, information that needs to be entered into the database covers the company, its contacts, an information form and the company's activities. They plan to install the module in which the products have to be entered at the end of June, he explained.
For those wanting to know more, an FAQ webpage on the registration process can be found at https://www.famhp.be/en/faq_webportal.