Medical device regulation (MDR)
Regulation (EU) 2017/745
Many questions arise concerning the MDR, regarding:Ä¢¹½´«Ã½‹
- Its impact on the continuous availability of Ä¢¹½´«Ã½ productsÄ¢¹½´«Ã½‹
- Details on its applicability for customersÌýandÌýusers of our medical devicesÄ¢¹½´«Ã½‹
Due to the extent and complexity of the new MDR, the new requirements have been implemented inÌýaccordance with dedicated implementation programmes and controlled byÌýsenior management in close coordination with our notified body.Ä¢¹½´«Ã½‹
Most of our product portfolio is already covered by our EU MDR certificates. Going forward, MDR compliance and full transition of the remaining MDD-certified products will be assured through the established global processes.
The followingÌýQ&A section will provide relevant information on the MDRÌýimplementation by Ä¢¹½´«Ã½, and its consequences forÌýcustomers and users of our medical devices.Ä¢¹½´«Ã½‹
Questions and answers
Does Ä¢¹½´«Ã½ fulfil the MDR requirements?Ä¢¹½´«Ã½‹
Conformity of Ä¢¹½´«Ã½s quality management system with the applicableÌýMDRÌýrequirements wasÌýassessedÌýand confirmed during external audits byÌýthe notified body in 2019.ÌýSince then, we are subject to regular surveillance / recertification audits regarding MDR conformity.Ä¢¹½´«Ã½‹
An equally important prerequisite for obtaining the MDR certification is the product verification in terms of conformity with the requirements of the MDR. After successful assessment of related Technical Documentations by the notified body, the vast majority of product categories have been successfully included in the MDR certification scope. The number of products conforming with MDR will constantly increase over the next years in line with the MDR transition provisions.
The respective EU certificates pursuant to the MDR that have been issued by the notified body will be updated accordingly with the respective product categories.
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When will all affected Ä¢¹½´«Ã½ products conform with the new MDR requirements?Ä¢¹½´«Ã½‹
Our medical devices will be placed on the EU market in conformity withÌýthe applicable EU requirements during the legally defined transition periodsÌýfrom the former MDD to the MDR.ÌýÄ¢¹½´«Ã½‹
Until end of December 2027 / December 2028 (depending on the classification of the Medical Device), productsÌýwhich have been certified under MDD can underÌýcertain conditions still be placed on the market after the MDR fully applies,Ìýas long asÌýtheir EC certificates are valid.ÌýÄ¢¹½´«Ã½‹
Accordingly,ÌýÄ¢¹½´«Ã½ will placeÌýboth MDDÌýand MDR certifiedÌýmedical devices on the market during this period and,Ìýuntil end of the respective transition periods (see section Ä¢¹½´«Ã½žMDR Transition timelinesÄ¢¹½´«Ã½œ,ÌýtheÌýÄ¢¹½´«Ã½ products with MDD certification will gradually beÌýcertified according to MDR. Adaptations to the FME portfolio may becomeÌýnecessary in this phase.ÌýÄ¢¹½´«Ã½‹
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Which changes in labelling are expected for MDR certified products?Ä¢¹½´«Ã½‹
MDR certified products require a Unique Device Identifier (UDI). The UDI is a series of numeric or alphanumeric characters that allows the identification of a specific device on the market. Specific symbols are needed for MDR certified products, examples are shown in the first illustration. The UDI code on MDR conform devices does not replace the article number, it is for product identification andÌýtraceability during the complete life cycle of the product*.Ä¢¹½´«Ã½‹
Please find an example for anÌýMDRÌýconformÌýgenericÌýsampleÌýlabel in the second illustration.
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What extent of product traceability must customers ensure regarding our medical devices after implementation of the UDI labelling requirement? Ä¢¹½´«Ã½‹
MDR certified products require a Unique device identifier (UDI). The UDI is a series of numeric or alphanumeric characters that allows the identification of a specific device on the market.
The EU Commission has published factsheets regarding the obligations that customers must observe (see link section below*).
- Unique device identifier (UDI)Ä¢¹½´«Ã½‹
- Authorized representatives, distributors, and importersÌýÄ¢¹½´«Ã½‹
- Healthcare professionals and health institutionsÄ¢¹½´«Ã½‹
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What is the relevance of the EUDAMED database?Ä¢¹½´«Ã½‹
The European Database on Medical Devices (EUDAMED) is a database managed by the EU Commission for the storing of information about medical devices.
The aim of EUDAMED is to strengthen market surveillance by providingÌýcompetent authorities with fast access to information on manufacturers,Ìýauthorized representatives, medical devices, certificates and vigilance data, to shareÌýinformation on clinical investigation data, as well as to contribute to aÌýuniform application of regulatory requirements, in particular in relation toÌýregistration requirements.Ä¢¹½´«Ã½‹
All manufacturers and all medical devices to be placed on the EU market willÌýbe registered in EUDAMED. Manufacturers (like Ä¢¹½´«Ã½)ÌýhaveÌýtoÌýensure that all data provided to EUDAMED are correct and up-to-date.ÌýData includes product related data, data from different market surveillanceÌýreports, and data concerning the registered economic operator.Ä¢¹½´«Ã½‹
Ä¢¹½´«Ã½ continues to take care ofÌýthe fulfillment of the requirementsÌýregarding EUDAMED registration and reporting in accordance with theÌýlegally defined timelines.
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