31 August 2018 - Authored by:
During the summer months of July and August, the European Commission has published five documents aimed at guiding manufacturers and other economic operators through the changes implemented by the EU Medical Devices Regulation (MDR) and the EU In-Vitro Diagnostic Medical Devices Regulation (IVDR). Both regimes will be fully applicable on 26 May 2020 and on 26 May 2022 respectively.
These guidance documents include factsheets and implementation models for both manufacturers of medical devices and manufacturer of in-vitro medical devices as well as an exhaustive list of requirements for medical devices manufacturers. They allow operational and legal teams to see the big picture on both Regulations. Manufacturers that have not yet started implementing the MDR can use these guidance documents as a first roadmap while manufacturers more advanced in the transition process could see them as a check list in order to ascertain that all the steps are covered by their action plan.
The factsheet focuses on major changes under the MDR and sheds light on the scope of the MDR, the definitions, the obligations of manufacturers, the risk class of devices, the notified bodies, the new device identification system, the conformity assessment and the clinical requirements as well as the summary of safety and clinical performance. It provides key points on the MDR background, changes implemented by the new regime and practical consequences as well as some timelines for the transition. The guidance document also provides a Q&A with some basic operational questions.
The MDR sets out more stringent requirements for the designation of Notified Bodies. The MDR has a wider scope and now covers additional devices (i.e. devices intended to clean, sterilize or disinfect other medical devices; reprocessed single use medical devices; certain devices with no intended medical purposes). In addition, it also reclassifies certain devices based on a risk analysis and introduces a clinical evaluation consultation procedure performed by an independent expert panel for some Class IIb devices and for implantable Class III devices (see our previous post: Getting ready for EU MDR: Classification of medical devices).
The scope of the new regime is broadened and clarified (e.g. devices and services sold online now clearly fall under the MDR). Economic operators such as the authorised representative(s), the distributors or the importers, have also their share of assignments and new liabilities (e.g. registration as an economic operator, checking out compliance of the devices) (see our previous post: Getting ready for the EU MDR : Obligations for economic operators). All certificates issued after 25 May 2017 under the previous MDD regime will be void at the latest by 27 May 2024. Devices meeting the old requirements within the supply chain will not be marketable and must be withdrawn on 27 May 2025 (see our previous post: Getting ready for the EU MDR: Timelines for manufacturers).
The manufacturer’s obligations are increasing with (i) corporate requirements (e.g. authorised representative is now mandatory for manufacturers established out of the EU), (ii) task force requirements (e.g. a person responsible for regulatory compliance shall be hired) and (iii) processes requirements (e.g. a risk management system, a quality management system –now including reinforced clinical evaluations- and a post-marketing clinical follow-up shall be implemented).
Traceability and effectiveness of the post market surveillance are straightened by the new Unique Device Identification system (UDI), while transparency will be increased by the new European Database for Medical Devices (Eudamed), which will enable patients to have access to some devices’ data.
The factsheet is based on the same model as the factsheet of Manufacturers of Medical Devices.
The In-Vitro Diagnostic Medical Devices Regulation is the legal basis for manufacturers and will replace the In-Vitro Diagnostic Medical Devices Directive (IVDD). The biggest change concerns the risk classification of in-vitro diagnostic devices (IVD) and the role of Notified Bodies. The IVDR uses international rules to assign each device to one of the four risk categories, ranking from Class A (lowest risk) to Class D (highest risk). Risk classification is now determined by the intended purpose of the device, taking into consideration risk to the individual and risk to the public health. Requirements for clinical evaluation and conformity assessment are tightened (e.g. Class D devices will require the involvement of an EU Reference Laboratory). As a result, it is estimated that 85% of all IVDs will need Notified Bodies’ oversight.
Both documents draw a list of actions to be performed in order to duly implement the MDR and / or the IVDR. Identifying stakeholders within your organisation is a key point before setting up any action plan.
As the MDR and the IVDR dates of application are approaching, this document is key to understand the authorities’ position and expectations while starting to draw the lines of an implementation plan within your organisation and in cooperation with your business partners. It provides a detailed list of requirements for manufacturers (i.e. process requirements, supply chain, conformity assessment, UDI and clinical investigation requirements) along with their legal grounds.
This post was co-authored by Marie Charrière.