EC issues medtech guidelines on implant cards required under MDR
the European Commission Medical Devices Coordination Group (MDCG) has published advice on which cards implant manufacturers must provide under the new EU medical device regulation.
The MDCG provided a non-exhaustive list of 88 types of medical devices that must be supplied with the equipment, as well as a sample implant card based on its previous guidelines.
- The group released the implant card orientation days after the publication of a question and answer document on the European Medical Device Nomenclature (EMDN) and information on the relationship between the terminology of the International Forum of Medical Device Regulators (IMDRF) and the MDR.
The MDR is now in effect, but the MDCG continues to add guidance to manufacturers. Since the date of application of the MDR of May 26, the coordination group has published five documents, most recently advice on the types of implants that should be supplied with the cards.
Regulations require that implants come with cards to allow patients to identify the device they contain, obtain product information, and ensure that they receive special care if needed, for example. example during security checks and emergency situations. MDCG provided advice on what information manufacturers should include on implant cards last year.
In its latest guidance, the MDCG shared an updated list of implants that must be supplied with cards “in order to help manufacturers assign an appropriate term to this requested information”. The MDCG said “a balance between the information a patient and healthcare professional need was the main driver behind the” suggested “device types.
The list of devices includes cardiovascular products such as pacemakers and mechanical mitral valves, as well as orthopedic implants, neural stimulators, breast implants and pelvic nets. Safety concerns of medical devices such as breast implants have been a driving force behind the development of MDR.
Separately, MDCG has posted answers to frequently asked questions about EMDN. The nomenclature of medical devices is intended to support the Eudamed database. The MDCG guidance explains how it created EMDN, the key principles and structure of the nomenclature, and how stakeholders can access the resource.
The MDCG released the nomenclature document the same day it released a text explaining the MDR and IVDR equivalents of the IMDRF principles and terminology on unique device identification. For example, the term “customizable” IMDRF is equivalent to “configuration” in EU regulations. Other parts of the document discuss how the IMDRF, MDR, and IVDR handle software identification.