Digital Health Mid-Year Review: Medical Devices Regulation
14 July 2020
The Medical Devices Regulation (MDR) represents a significant development of the existing regulatory system for medical devices in Europe. It will replace the existing Directives which have been operative for over 25 years. The legislation being in the form of a Regulation, rather than a Directive, means this EU legislation will be directly applicable without requiring transitional national legislation. This should provide for greater legal certainty and prevent variation in the approaches adopted between Member States.
The new Regulations seek to overhaul the regulatory framework of medical devices, with the aim of improving clinical safety and creating fair market access for all manufacturers. Originally, it was set to come into force on 26 May 2020, however, largely due to COVID-19 this date has been extended by up to 12 months. This means that the MDR will now be fully applicable from 26 May 2021. The implementation of the In Vitro Diagnostics Medical Devices Regulation (IVDR) will follow a year later and will be enforceable from May 2022. We examine what the MDR seeks to achieve and the position we have gotten to so far for its revised date of implementation.
The MDR’s goal
The MDR addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and by imposing enhanced requirements regarding traceability of devices throughout the supply chain. Manufacturers will be required to demonstrate that their medical device meets the relevant requirements through conducting conformity assessments which are dependent on the classification of their device. Once a product has passed the conformity assessment, only then can a CE marking be affixed. Approvals under these conformity assessments are required for Class IIa, IIb and III medical. Some Class I devices will require a conformity assessment by a notified body, for parts relating to sterility or metrology, if the medical device includes sterile products or a measuring function.
The new MDR now requires total life cycle traceability between all stages of product development and post-market activities. Companies with low-risk Class I devices are required to produce a post-market surveillance report.
Labelling requirements have also been overhauled. General safety and performance requirements (GSPR) checklists have been mandated. Information on warning, precautions or contraindications on devices have also been made mandatory as part of the labelling process. Labels require the EC representative’s name, address and symbol. Additionally, clinical evidence is now required for all medical devices. This involves extensive clinical testing in some cases.
There have been two corrections or corrigenda to the MDR.
The first Corrigendum published in May 2019 in the Official Journal of the European Union (OJEU) related to amending linguistic and other minor errors.
The second Corrigendum was prepared by the Council of the EU on 3 December 2019. This correction of the MDR amends Article 120, entitled the “Transitional provisions”, to permit manufacturers of Class I devices under the Medical Devices Directive (MDD) who will be up classed under the MDR to avail of a four-year transitional period. Accordingly, manufacturers will be able to place these devices on the market until May 2024 and are further allowed to make these devices available to end-users until May 2025. In order to avail of this, a device must obtain a CE marking as a Class I device under the MDD before 26 May 2020 - now 26 May 2021 as a result of the delay. In addition, no significant changes can be made to the intended purpose and design of relevant device past 26 May 2021.
The European Commission proposed delaying the Regulation implementation date on 3 April 2020, so as to ensure the “continued availability of vitally important medical devices” during the current pandemic. The amending regulation was published in the Official Journal of the EU on 24 April 2020. 26 May 2021 is now the official date of full application.
The European Commission held the postponement was essential for the new regulatory system under the MDR to be “more solidly established and brought to full functionality”.
The biggest effect of this delay is that it takes a lot of the pressure off, at a time when all systems are stressed beyond their maximum capacity. Notified bodies would not have been able to conduct on-site audits, some products may not have been certified leading to disruptions in the continuity of supply and shortages of essential medical devices would have resulted during the current global health crisis.
This will help all parties focus on the current and pressing battle against COVID-19.
The MDR has significantly increased the requirements which must be fulfilled before being designated as a notified body. These new requirements relate to organisation & general requirements, quality management requirements, resource requirements and process requirements.
The designation process involves national and European assessments, which takes a minimum of up to 18 months, after which they can then certify devices under the new MDR requirements. As of the end of January 2020, over 85% of European Notified Bodies currently operating had applied for designation under the MDR, however at present, there are only 14 accredited notified bodies across Europe as listed on the attached link.
With 44 Notified Bodies still in the process of obtaining designation under the MDR, concerns had arisen about these organisations’ capacity to support medical device manufacturers’ European certification requirements past the May 2020 compliance deadline. The one year delay will now provide much needed time for pending submissions to get accreditation.
MDCG guidance documents
The European Union’s Medical Device Coordination Group (MDCG) has published guidance documents to assist stakeholders in implementing the MDR and with the objective of ensuring uniform application of the relevant provisions of the Regulation. To date the MDCG has issued a total of 50 guidance documents, including the following:
- Guidance on Software
- Clinical Investigations
- Clinical Evaluations
The MDR seeks to significantly change the regulatory environment of medical devices with traceability, safety and proven usability at the forefront. With only 14 notified bodies through the assessment process, the medical device industry was far from ready for its May 2020 date of implementation. COVID-19 has granted a much needed extension to its date of application across all EU Member States. As a result, industry players should make use of this grace period to better equip themselves for the revised 2021 date of application.
Unlike the previous EU legislative governing provisions, the new legislation takes the form of a Regulation, meaning no discretion is provided to national Member States and all provisions are directly applicable. As examined, the new Regulation is far more rigid and thus, preparations should commence as soon as possible to ensure smooth compliance.
For more information, please contact a member of our Product Regulation & Consumer Law team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.