After a prolonged wait, the MDR finally came into force on 26 May 2021, replacing existing Directives which have been operative for over 25 years. As a follow on to our previous articles preparing for this important change, we examine where we are now and what issues and challenges manufacturers and developers need to be aware of now that the MDR is in force.
The MDR’s goal
The MDR introduces sweeping changes to the regulation of medical devices in the EU including but not limited to the following:
Enhanced general safety and performance requirements for devices, with requirements in relation to labelling being particularly detailed
An increased focus on clinical data and the absence of ‘grandfathering’ provisions for devices that have been on the market for an extended period of time under previous legislation
More stringent requirements regarding the activities of notified bodies
Enhanced recognition of the role of software as a medical device
Increased transparency and traceability requirements illustrated through the rollout of the updated EUDAMED database and Unique Device Identifiers (UDIs), and
Stricter requirements on clinical evaluation and post-market surveillance that signify a shift in focus towards ensuring compliance throughout the entire life cycle of a device
Although the various requirements under the MDR are now in force, manufacturers of Class I devices that obtained a CE marking under the old Medical Device Directive before 26 May 2021 may avail of transitional provisions that allow for a four-year transition period. Accordingly, manufacturers of these devices are permitted to continue to place them on the market until May 2024 and are further allowed to make these devices available to end-users until May 2025.
However, manufacturers availing of these provisions need to take care to ensure that no ‘significant changes’ are made to the intended purpose and/or design of the relevant device after 26 May 2021. If such a ‘significant change’ is made to the device, this will trigger a requirement for certification of the altered device under the MDR. Although the MDR contains no definition of ‘significant change’, guidance on this issue has been published by the Medical Device Coordination Group (MDCG).
The MDR has significantly increased the requirements which must be fulfilled before being designated as a notified body, a process that involves rigorous national and European audits which can require a minimum of up to 18 months. If successfully accredited, a notified body may then offer conformity assessment services and certify devices under the new MDR requirements.
In the run up to 26 May 2021, significant concerns had been expressed in relation to the low number of notified bodies applying for and securing accreditation as a notified body under the new MDR regime. Now that the MDR is in force, the current figure for notified bodies offering services under the MDR stands at 20. Although further organisations are in the process of securing accreditation. The ability of what is expected to be a smaller pool of organisations to provide conformity assessment services to manufacturers under both the MDR will continue to be a concern.
In the run up to 26 May 2021, the MDCG has continued to publish guidance documents to assist stakeholders in implementing the MDR. Since our last update, the MDCG has issued further guidance, bringing the total to over 70 documents, including the following published in the last few months:
MDCG 2021-8: Clinical investigation application/notification documents (May 2021)
MDCG2021-6: Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation (May 2021)
MDCG 2021- Rev. 1: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (May 2021) (update) – covered in further detail in our article here
MDCG 2021-5: Guidance on standardisation for medical devices (April 2021)
While the work of the MDCG to develop and deliver further guidance continues, manufacturers should carefully monitor the relevant European Commission resources for updates.
Although recently published MDCG guidance on standardisation for medical devices provides a useful description of the concept of “state of the art” in the medical device context, along with the role of harmonised European standards in conferring a presumption of conformity with legislative requirements, it remains the case that there are currently no such standards published in the Official Journal of the European Union in respect of the MDR.
Harmonised European standards in the field of medical devices, are developed by the two relevant European standardisation organisations:
The European Committee for Standardization (CEN), and
The European Committee for Electrotechnical Standardization (Cenelec)
As confirmed in the guidance, the various standardisation mandates issued by the Commission to CEN and Cenelec in relation to the old Directives expire with those pieces of legislation. Added to this, a standardisation request issued by the Commission under the MDR to CEN and Cenelec in the form of a Commission Implementing Decision was rejected in May 2020.
On 14 April 2021, the Commission adopted an amended implementing decision, requesting CEN and Cenelec to revise some 201 existing harmonized standards and draft 27 new standards over the next three years. If accepted, implementing decisions with updated harmonised standards will begin to be published periodically in the Official Journal throughout the remainder of 2021. CEN and CENELEC have also been asked by the Commission to submit a joint work program by 28 May 2021. Given the importance of harmonised standards to industry, this is another area that manufacturers should closely monitor.
Although the MDR is now in force, the process of learning to live with a regime that requires a much higher degree of transparency, traceability and data has now begun in earnest. Added to this, manufacturers also need to plan for a number of structural challenges such as the continued wait for EUDAMED and limited capacity amongst notified bodies.
Although the coming into force of a major new piece of legislation is by its very nature disruptive, there are some practical steps that manufacturers and developers can take to successfully navigate the journey to a fully functioning new regulatory regime for medical devices under the MDR:
With a view to streamlining the conformity assessment process as best as possible, stay in close contact with notified bodies regarding audit timelines, capacity and operational/administrative requirements.
In cases where there is a dearth of guidance or lack of clarity, be prepared to explain and justify decisions made to notified bodies and regulators, ideally with the aid of documents demonstrating that the issue(s) in question have been scoped and appropriately analysed before a decision is made.
Continue to pro-actively monitor for updated guidance and harmonised standards. Have regard to the EU Commission implementation rolling plan and regularly check the EU Commission webpage where MDCG endorsed documents and other guidance are published.
Given the detailed information to be entered, and the care required in order to provide data in an organised and accessible format, learning how to navigate the various modules of the EUDAMED database as they come on stream will also assist in managing the resources required to ensure full adherence with this new system.
For more information on the scope of the MDR and its impact on your business, contact a member of our Product Regulatory team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.