The EU Medical devices Regulation
Cooley’s Productwise Bitesize brings you a short overview of the EU Medical Devices Regulation.
What is it called?
The Medical Devices Regulation (MDR Regulation (EU) 2017/745) governs the placing on the market in the European Economic Area (EEA) of medical devices and its accessories as well as clinical investigations taking place in the EEA. It has been applicable to clinical investigation sponsors, manufacturers, importers, distributors and online sales by distance of medical devices in the EU since 26 May 2021
What is it about?
The MDR is primarily designed to ensure that medical devices placed on the EEA market fulfil applicable safety and efficacy requirements and that the medical devices are traceable throughout the supply chain.
Prior to the MDR medical devices were governed by the Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on Active Implantable Medical Devices (AIMD). In vitro diagnostics devices, which were previously governed by Directive 98/79/EC on in vitro diagnostic medical devices, are now governed by the IVD Regulation (Regulation (EU) 2017/746). The MDR also introduced new requirements regarding clinical investigations, the Technical Documentation that must be prepared for medical devices as well as stricter requirements on clinical evaluation and post-market clinical follow-up. Furthermore, the MDR requires implementation of better traceability of devices through the supply chain compared to the related obligations imposed by the MDD and AIMD.
The MDR introduces a definition of the roles of various economic operators such as importers and distributors and provides for specific obligations that individual economic operators must fulfill. While the obligations that economic operators must fulfil were previously set down in guidance documents, such as the MEDDEVs, these obligations are now enshrined in the MDR. Unlike its predecessors the MDR, as a Regulation, does not require national implementing legislation of the EU Member States thus ultimately leading to a more harmonized approach to the marketing of medical devices in the EEA. However, there may still be national requirements introduced in individual EU Member States such as the language to be used on packaging and labels of medical devices, advertising and promotion, as well as regarding conduct of clinical investigations.
Who and what does it apply to?
The MDR is applicable to manufacturers, importers, distributors and online sellers that supply medical devices for the EEA. The MDR also provides for requirements concerning certain devices that do not have a medical intent including esthetic contact lenses, eyeball implants, dermal fillers and intense pulsed light machines for body hair removal. These devices are listed in Annex XVI to the MDR.
The MDR includes transitional provisions for those medical devices that have been available on the EEA market prior to the date of application of the Regulation. The possibility to rely on the transitional provisions is subject to strict requirements and conditions. These provisions are not automatically applicable to all medical devices previously marketed in the EEA.
Why does it matter?
Given the extensive and stringent requirements that govern the placing on the market of medical devices in the EEA it is essential to ensure that a medical device is classified correctly, that all related obligations imposed by the MDR are documents and fulfilled, and that all the economic operators responsible for manufacture and distribution of the devices in the EEA fulfil their obligations appropriately. Non-compliant devices and the economic operators placing these on the market in the EEA may face regulatory enforcement actions by the competent authorities of the EU Member States.
Clinical investigations tend to be time consuming and expensive. To save time and costs it is essential to develop a regulatory strategy regarding clinical investigations necessary to generate the data required to comply with requirements concerning clinical data that are imposed by of the MDR. Sponsors of non-compliant clinical investigations may have their clinical investigation applications delayed or rejected.
Furthermore, engaging with economic operators without having a strategy and compliance framework in place may cause delays and confusion both in relation to such interactions and in marketing medical devices in the EEA. Economic operators marketing medical devices that are not compliant with the requirements of the MDR may face enforcement actions by the competent authorities of the EU Member States.
Where can I find it?
The MDR is available here.
Is there any guidance?
The Medical Devices Coordination Group (MDCG) of the European Commission has published a number of related helpful guidance documents available here. This guidance documents are the successors to the MEDDEV guidance, published by the European Commission for the predecessors of the MDR, the MDD and the AIMD. The Competent Authorities for Medical Devices (CAMD) has also published helpful guidance, in particular on transitional provisions regarding medical devices that were already placed on the market prior to 26 may 2022. This guidance is available here.