How the transition to the Medical Device Regulation unfolded
The Medical Device Regulation reached application through a transition period set by its legislation, a period that notified bodies and manufacturers entered short of capacity and guidance, that the COVID-19 pandemic lengthened by a year, and that was extended again once application had begun.
From proposal to date of application
In 2012 the European Commission published its proposals to replace the Medical Device Directive with two regulations, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). In 2014 the European Parliament responded with a list of amendments, and in 2015 the Council stated its informal position on the proposals. The Commission, the Council and the Parliament then discussed the proposals to reach agreement, and the agreed texts were published in June 2016. After translation into the official EU languages and legal-linguistic checks, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices were formally adopted by the Parliament and the Council on 5 April 2017. They were published in the Official Journal of the European Union in May 2017 and became legally binding on the twentieth day after publication.
Entry into force opened a transition period of three years for the MDR and five years for the IVDR before each became fully applicable, so that the Commission, the competent authorities, the notified bodies and the manufacturers could meet their obligations from the date of application. The dates of application were set at 26 May 2020 for the MDR and 26 May 2022 for the IVDR.
Readiness as the date approached
In 2017, just after the MDR's approval, one writer with long experience in device corporations expected the transition years to be difficult for every stakeholder until manufacturers and authorities adapted to the changes, with a first year that would be a struggle and a hazardous game with an open end, after which they would settle into a reasonable cooperative scheme. In 2019 the months leading to the MDR's date of application were expected to bring much uncertainty and many challenges for medical technology companies. Compliance with the IVDR was expected to be a bigger challenge than compliance with the MDR.
Because the requirements for designating notified bodies under the new regulations were stringent, the number of notified bodies could be much lower than before, and the Commission estimated that it would designate 20 by the end of 2019. As of July 2019 the Commission had designated only two for the MDR, BSI UK and TÜV SÜD, and none for the IVDR, which would increase the notified bodies' workload and add to the challenges manufacturers faced in ensuring compliance. Notified bodies, not only manufacturers, had to adapt, and the MDR's effect on them was significant: by 2019 TÜV SÜD had almost doubled the size of its team to support the duties the regulation required. UK notified bodies certified a substantial number of devices for the EU market, and the Commission stated that in a no-deal Brexit every device certified by a UK notified body had to comply with the EU's import requirements.
In 2019 many guidelines and common specifications were still being written, so many changes were still to come, and the common specifications for clinical investigations, clinical evaluation and post-market clinical follow-up would give writers more guidance once they were finalised.
The postponement of application
The European Commission adopted a proposal to postpone the MDR's date of application by one year, to 26 May 2021, because of the COVID-19 pandemic, so that essential devices would remain available and manufacturers could prioritise their efforts to fight the pandemic. The proposal received the full support of the Parliament and the Council through an accelerated co-decision procedure, so that it could take effect before the original date of 26 May 2020. The European Council voted for the delay, recognising "the need for an increased availability of vitally important medical devices across the EU" and stating that patient health and safety continued to be guaranteed until the new legislation applied. With the postponement, devices marketed in the EU and the European Economic Area had to comply with the MDR by May 2021.
The IVDR's date of application stayed at 26 May 2022, and because it and other associated deadlines had not moved, industry still had to prepare. The MDR's transition period thus became four years, and it applied from 26 May 2021, replacing Directives 90/385/EEC and 93/42/EEC, while the IVDR kept its five-year transition period and applied from 26 May 2022, replacing Directive 98/79/EC.
In a poll at a virtual seminar on devices on 9 June 2020, the participants believed the one-year delay was appropriate; the seminar had 39 participants, most of them with less than five years' professional experience in the device industry. The delay gave industry more time to prepare for the transition, but many questions about readiness for the MDR remained, and demand for more such sessions across industry could be expected until May 2021. In June 2020 drug-device combinations and Eudamed were two of the many open concerns surrounding the MDR, and preparing Eudamed submissions in time for the date of application was important.
The first year of application
The MDR and the IVDR both required particularly far-reaching changes in the way the sector operates and important efforts to adapt, made harder by the COVID-19 pandemic of 2020 and 2021, which seriously affected the ability of those involved to prepare.
In mid-2022 two medical writers working in the device industry described implementing the MDR, which coincided with the pandemic, as an uphill battle for most in the industry, with uncertainty from remote working and from a lack of prompt clarification, whether about the number of notified bodies available to handle the workload or about interpreting the regulation, for which guidance was insufficient. In their view the device industry nonetheless came through victorious.
By its own account in mid-2022, the European Commission had worked closely with national competent authorities, notified bodies and the European associations of health professionals, patients and industry on implementing the regulations. Its work included implementing acts for designating notified bodies, harmonised standards and common specifications, the ongoing development of Eudamed, the assignment of unique device identifiers, the European Medical Device Nomenclature, the designation of expert panels, and the setting up of the Medical Device Coordination Group (MDCG) and its 13 subgroups. By then more than 90 guidance documents had been published after discussion and endorsement by the MDCG, which the Commission chaired and managed with the participation of competent authorities and stakeholders, and the Commission published other guidance documents and factsheets directly.
In the Commission's assessment in mid-2022, the number of notified bodies under the MDR and IVDR was growing and their capacity and resources had increased, but the situation was still challenging and more progress was needed. To address the challenges of the COVID-19 crisis and the lack of notified bodies, notably under the IVDR, the Commission prepared amendments to both regulations on the dates of application of certain provisions and on the related transitional regimes. The Commission held the amendments necessary to take some pressure off the national authorities, notified bodies, manufacturers and others handling the pandemic while securing a smooth implementation, and the Parliament and the Council adopted them through very speedy co-legislative procedures.
Much work remained for the following months and years to deal with the challenges of the new framework and to avoid shortages of critical devices, challenges that affected member states, economic operators, conformity assessment bodies, patients, users and citizens in different ways. To respond to these challenges jointly, the Commission services were working to provide support, counting on the commitment and active participation of all the parties, for a secure, smooth and timely implementation of the framework.
The extension of the transition
In 2023 Europe had more than 33,000 medical technology companies, 95% of them small or medium-sized, and these smaller companies evidently took the brunt of the transition's hurdles. Updating the outdated directive was necessary, but the challenges of implementing the MDR were affecting the cost and predictability of compliance and, ultimately, the availability of products on the EU market. Regulators first became aware of the risk of products becoming unavailable in October 2021, especially for high-risk devices whose certificates would expire in May 2024.
In December 2022 a proposal was made to amend the transition period for devices to curtail the risk of impending shortages. When the amendments were released as Regulation (EU) 2023/607 in March 2023, the industry scrambled to understand the many conditions a device had to meet to qualify for the extended timelines, and many questions remained open.
What the transition asked of writers
In 2019 a notified body's clinical audit director strongly recommended that writers read all of the MDR and keep monitoring new developments as its parts took effect. Because the new legislation came with a three-year implementation period, the outgoing directive might still be worth consulting while its replacement was on its way.
In 2020 medical writers were expected to have a key role in guiding manufacturers as they adapted to the changes. One view, given to device writers in 2023, is that however the timelines for compliance move, medical writers remain best equipped to understand what the regulation means for writing.