As of May 1, 2021, notification of the insertion and removal of implantable devices will become mandatory in Belgium for stents, mechanical cardiac and ophthalmological implants, as well as some other implants included in Annex to the Royal Decree, while the list of devices might be extended.
The Central Traceability Register aims at improving the traceability of implants distributed, prescribed, dispensed, implanted and removed in Belgium, as well as ensuring greater transparency for the patient and the possibility to react quickly in case of incidents.
The Central Traceability Register (RCT) will be updated by health professionals. The FAMHP calls for voluntary notification to the RCT at this stage already.
Patients will access to the Register too. The patient will be able consult all notifications of implants and/or removal of implants concerning them. They can also download their patient card. Which will show all notifications in a single document.
Linked to the topic of implants, one should not forget the new requirement under the upcoming Medical Device Regulation (with date of application being May 26, 2021), namely Article 18 that requires from the manufacturer of implantable devices to provide information and an implant card to the patient.
The manufacturer of an implantable device shall provide together with the device the following:
(a) information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;
(b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;
(c) any information about the expected lifetime of the device and any necessary follow-up;
(d) any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.’’
The above means that the manufacturer should provide to the patient booklet to the patient with the above information, in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website of the manufacturer.
Moreover, the manufacturer should provide, together with the device, an implant card, which shall allow identification of a device, including:
- Device name;
- Device type;
- Serial number or, where applicable, lot or batch number;
- Unique device identification (UDI); the UDI as AIDC4 format and the UDI-DI as HRI5;
- Name and address of the medical device’s manufacturer;
- Website of the manufacturer of the medical device where additional information on the device can be found.
In addition, the implant card should in addition contain blank fields, which shall be filled out by the health institution or healthcare provider, respectively:
· Name of the patient or patient ID;
· Name and address of the health institution or healthcare provider who performed the implantation;
· Date of implantation.
For the Belgian market, the above implant card shall be provided by the manufacturer in one of the three national languages or in English, at the choice of the patient or their representative[1].
[1] · Belgium: Avant-projet de la Loi relative aux dispositifs médicaux (Draft)
Ajda Mihelcic
DPM Publications department & Content Manager of MDlaw.eu
25/11/2020
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References:
- https://www.famhp.be/en/news/central_traceability_register_the_traceability_of_certain_implants_to_become_compulsory
- Avant-projet de la Loi relative aux dispositifs médicaux (Draft)
- MDCG 2019-8 v2 – Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices