This regulatory topic has become increasingly pertinent, ahead of the countdown to the EU's new medical device and in-vitro diagnostic rules, set to take effect on May 26, 2020 and 2022, respectively.
Currently, there are more than 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Robust regulation that ensures a supply of safe devices, and allows monitoring of the introduction and use of medical devices, is essential.
The new Medical Device Regulation (EU) 2017/745 was published in the Official Journal of the European Union and came into force on May 5, 2017, replacing two existing Directives:
1. Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2. Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in-vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
The new regulations apply after a transitional period. Namely, three years after entry into force of Regulation (EU) 2017/745 on medical devices (May 26, 2020), and five years after entry into force (May 26, 2022) of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices.
Existing devices which have been CE marked under the current Medical Device Directive (MDD) must be recertified to abide by the new MDR.
The new regulations aim to enhance patient safety and modernise public health, by introducing an enhanced governance framework around the definition, supervision, traceability and risk-based classification system for medical device equipment.
Some key elements of the new legislation include:
- Expansion of the definition of medical devices: The breadth of medical devices has been significantly expanded and includes certain products which previously did not fall under the definition of a medical device. For example, eye contact lens solution, liposuction equipment and laser equipment used for hair and tattoo removal.
- Enhanced vigilance and market surveillance: Once devices are available for use on the market, manufacturers will be obliged to collect data about their performance, and EU countries will coordinate more closely in the field of market surveillance. The new regulations will ensure vital information is easy to find through more stringent traceability measures. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product.
- EUDAMED database: The Commission will establish a centralised EU database for the storage of information on medical devices (EUDAMED). This will facilitate the communication of both pre- and post-approval product information between economic operators, the Commission, member states and, in some cases, healthcare professionals and the public.
- Tighter regulatory controls: The new rules will impose tighter pre-market controls on high-risk devices, and apply a more rigid approach to the conduct of both clinical evaluation and the clinical investigation of clinical trials. The MDR will require device manufacturers to conduct clinical performance studies and provide evidence of safety and performance, proportionate with the risk associated with a given device. EU cross-border clinical trials will be subject to a single coordinated assessment. Stricter requirements on the use of hazardous substances will also be introduced, and device manufacturers will be required to collect and retain post-market clinical data, as part of the ongoing assessment of potential safety risks.
- Introduction of a risk based classification system: A new system for risk classification, in line with international guidelines, will apply to in-vitro diagnostic medical devices, in addition to a wider medical device classifications definition for all products. While the classification system (Class III, Class IIa, Class IIb and Class I) will be retained, some rules have been tightened. This may result in a significant number of product types – previously exempt from the regulations – now being included in the scope. Manufacturers will need to demonstrate that their medical device meets the requirements in the MDR and IVDR by carrying out a conformity assessment. The assessment route depends on the type and device classification.
- Post Market Surveillance System (PMSS): As part of their quality management system, manufacturers must also establish a PMSS, which should be proportionate to the risk class and the type of device in question. Manufacturers will have to report all incidents, injuries and deaths into an EU portal that will contain relevant data, so patients have access to safety-related information.
- Responsible Person (RP): Medical device manufacturers and authorised representatives will be required to designate at least one person with responsibility for regulatory compliance; that person(s) must hold the prerequisite academic expertise and work experience in the field of medical devices.
- Financial compensation measures must be in place: The regulations require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability. Such financial coverage must be proportionate to the risk class, type of device and the size of the enterprise.
Medical device manufacturers must prepare for regulatory changes
During the present transition period up to May 2020, manufacturers can choose to comply with either the existing MDD/AIMDD legislation requirements, or the new MDR.
However, as all medical device products marketed in the EU must eventually comply with the MDR, and any changes to pre-MDR products after full application of the MDR negate MDD compliance, companies are advised to define their strategies for regulatory transition.
Comparing and contrasting regulatory differences between the existing MDD and the new MDR is important. As it is highly likely for most legacy devices that a review of MDR requirements will identify regulatory issues that will need to be addressed for every device.
Complying with the new MDR will prove a high task for most medical device manufacturers. Guidance and implementing measures under the current Directives will be reviewed by authorities over the next few years, in light of the new regulations.
At this present stage, the European Commission has a published list of legally non-binding guidance documents adopted by the Medical Device Coordination Group, to support the industry's efforts to apply relevant provisions of the MDR. These include consensus statements, informative documents and MEDDEVs for medical device manufacturers, authorised representatives, notified bodies, and competent authorities.
In addition, on October 30, 2018, the European Commission published the most recent version of the Borderline & Classification Manual. This document provides guidance on establishing the status of medical devices and IVDs, as well as their risk classifications. The current version, version 1.20, replaces version 1.19 released in April 2018.
The new medical device regulations in Europe present a huge challenge to manufacturers, but could also deliver improved confidence in the consistency and effectiveness of the EU regulatory process.
Cliodhna McDonough is a qualified clinical dietitian and a life sciences regulatory lawyer at law firm Stephenson Harwood LLP.