A seismic shift9 June 2021
After years of fevered speculation, and maybe even a few weeks of planning, OEMs awoke on 26 May 2021 to find that the EU’s new Medical Device Regulation had become legally binding. Gabriel Adusei, associate director at Guidehouse Europe, explains how companies and regulators are adapting to the shifting environment.
The new European Medical Device Regulation (MDR) 2017/745 is perceived as one of the most extensive and robust regulations in the world. It was published in the Official Journal of the European Union on 5 May 2017 and “entered into force” 20 days later on 26 May 2017.
It must be noted that ‘entering into force’ is not the same as becoming applicable. The Medical Device Directive (MDD) 93/42/EEC remained applicable through the transition to the new MDR. The date of application was also postponed from 26 May 2020 until 26 May 2021. This was seen as a ‘grace period’ for the industry as it dealt with the impacts of Covid- 19. Despite the extra time to review and prepare for MDR, there are a number of elements that have continued to pose a challenge to manufacturers.
One of the most significant changes concerns the way in which medical devices are classified. The scope of MDR has been expanded to include products that do not have an intended medical purpose but carry similar risks to medical devices. Examples of these devices are listed under Annex XVI and they include products such as fashion contact lenses, sunbeds and liposuction equipment. In addition, devices that are used for cleaning, sterilisation and disinfection, such as autoclaves and contact lens cleaning solutions, are now considered medical devices in their own right and fall under the scope of MDR.
MDR has 22 rules for classifying a medical device; an increase of four rules compared with its predecessor. These rules must be read carefully by manufacturers as they may result in a classification change for some devices, according to their risk, contact duration and invasiveness. In particular, Class III and implantable devices will have higher clinical requirements and be subject to a regular scrutiny process. MDR also introduces a new classification, Class Ir, for reusable surgical devices. Unlike other Class I devices, Class Ir devices require notified body involvement.
Furthermore, there are no ‘grandfathering’ provisions in MDR. All currently certified medical devices and active implantable medical devices must be recertified in accordance with the new requirements. This ties in with increased regulatory expectations for clinical evaluation. MDR requires that manufacturers conduct clinical investigations to demonstrate their products’ compliance with Annex I. It is important to note that for legacy devices, manufacturers must conduct a comprehensive gap assessment against Annex I and identify if there are any gaps in the clinical data for their device that may prevent recertification. Under MDR, manufacturers must also conduct post-market clinical follow-up (PMCF) and, using the data collected, update the clinical evaluation for the device. The data and information derived from the PMCF must also be entered on EUDAMED.
Acknowledging the advances in the development and use of software for activities such as patient monitoring, MDR’s Rule 11 specifically focuses on the classification of software dependent on its intended use. Many software applications that were regulated as Class I under MDD are now Class II or higher under MDR.
Another important change under Article 15 of MDR is the requirement for a ‘person responsible for regulatory compliance’ (PRRC). The PRRC is employed by either the manufacturer, or, in the case of manufacturers based outside the EU, its authorised representative, and has very specific responsibilities. These include ensuring that unacceptable or defective devices are not released to the market, and that post market surveillance and vigilance reporting requirements are fulfilled. MDR imposes strict educational and experience requirements on each PRRC in respect of the importance of the role in safeguarding regulatory compliance.
The introduction of a full unique device identification (UDI) system for better traceability and recall is a key MDR addition, but a lack of clarity about how manufacturers should implement it has caused issues. There is still confusion around how labelling and packaging should incorporate UDI information, especially if the manufacturer’s target markets are international and cover different regulatory jurisdictions. Within Europe, as a result of the postponement of a number of its modules, the use of EUDAMED will be limited until 2022, further hampering some UDI operations.
The price of preparation
OEMs and the wider medtech industry have had the opportunity to review MDR and its impact since it was published. In principle, it could have been adopted by manufacturers of medical devices immediately after its entry into force in May 2017. However, the implementation of the new infrastructure that undergirds MDR (the new EUDAMED database, and the new registration and reporting procedures, for example) is ongoing, limiting what individual companies can do. In addition, designation of the notified bodies under the new regulation has taken some time, and many more may yet be required.
The MDR application, auditing and designation process takes a great deal of effort from notified bodies, which translates into various unexpected costs and price increases. Moreover, to meet the new regulations, notified bodies are required to restructure their organisation and increase resources to provide relevant services, further increasing production costs, and necessitating the hiring and training of new staff, all of which takes time. Overall, MDR demands higher regulatory oversight, which means additional and regular assessment, resulting in higher total certification costs within a period of five years. Specifically, there are more rigorous clinical testing requirements to support clinical evidence for Class III and implantable medical devices. Manufacturers will need to conduct extra clinical investigations if they do not have sufficient clinical data to demonstrate both safety and performance of a dedicated device according to MDR’s exacting standards. For Class IIa and Class IIb medical devices, meanwhile, manufacturers will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach can be taken and under which circumstances it is possible to justify not conducting a clinical investigation. There is also a stronger emphasis on post-market surveillance, requiring more rigorous oversight from notified bodies to reduce risks from unsafe devices.
For all of that, the companies that began thinking about MDR early are those who have found the transition smoothest. They have been able to accommodate hold-ups, train personnel, consult with experts and, when in doubt as to how to meet a particular requirement, get clarification from notified bodies and competent authorities.
In fact, the EU’s regulators have been supportive and mindful in handling the transition. For them, working closely with the industry is key to making MDR functional. By doing so, they can better ensure the safety and efficacy of approved products. They have also paid close attention to economic impacts and the Covid-19 pandemic, altering regulatory requirements for key products and devices as necessary. That said, areas for improvement include the preparation and publication of guidance documents, as well as the readiness of infrastructure such as EUDAMED to support the regulation.
The spirit and the letter
In spirit, MDR exists to improve regulatory processes and ensure the safety of products all the way from the manufacturers to the end-users, but its advantages and disadvantages are a matter of perspective. Depending on how one looks at it, increased regulatory scrutiny, additional responsibilities and a wider definition of medical devices could be important steps towards ensuring safety or a costly limit on innovation that prevents patients getting the devices they need. One thing everyone can agree on is that the cost of achieving and maintaining regulatory compliance has shot up under MDR.
There’s also less room for manufacturers to have their own perspective when it comes to the specific requirements of MDR. Although extensive documentation on quality, safety, efficacy and resources are needed to demonstrate compliance, the text offers little or no room for different interpretations of the regulation. In contrast, MDD allowed diverse interpretations, which could potentially lead to errors. The spirit of MDR is to offer a streamlined regulatory process, so it also offers more training and consulting opportunities to help companies prepare.
Ultimately, revision to the way medical devices were regulated was required following incidents such as the Poly Implant Prothese breast implant and the metal-on-metal hip implants scandals. The EU MDR provides a robust regulatory framework for ensuring that safer products that operate as intended are approved for use to improve health outcomes. The high cost is one of the key factors in attaining CE certification but quality, safety, and efficacy cannot be compromised and MDR is the right approach for ensuring this. Re-evaluating the strengths and weaknesses of the regulation itself as part of the transition process could help companies make better progress towards attaining or maintaining CE certification.
Key dates for MDR implementation
- 26 May 2021: Date the EU MDR became legally binding. The original 2020 deadline for application was delayed due to the coronavirus pandemic.
- 26 May 2022: Earliest date EUDAMED is estimated to go live. The European Commission will make some EUDAMED modules available in 2021 but decided to delay its full application.
- 26 May 2024: Certificates issued under MDD become void. This is the last date for placing medical devices on the market unless they meet MDR requirements. Thus, notified body certificates issued under MDD designation become void (if not already expired).
- 26 May 2025: Last possible date for putting devices into service according to MDD. After this point, end-users (hospitals, for instance) can no longer put MDD products into service.
Gabriel Adusei, associate director, Guidehouse Europe
Dr Gabriel Adusei has over 30 years of experience in the medical device industry, with periods in research and academia. He is acknowledged as a thought leader, having worked on many high-profi le projects in the medical device technology industry in different capacities, and his numerous publications have also infl uenced recent industry developments.
MDR and Brexit
When the UK left the EU on 31 January 2020, it operated and observed EU laws through a transition period that ended on 31 December 2020. From 1 January 2021, the EU and UK have operated as separate sovereign jurisdictions subject to agreements on individual matters. While the medtech industry was preparing for the ‘date of application’ of MDR with all the accommodations and adjustments made as a result of the Covid-19 pandemic, the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) were updated for the UKCA mark.
This means companies with marketing interest in both the UK and EU should make preparations to comply with two separate regulatory regimes, although, until 30 June 2023, the UK will accept CE-marked medical devices if they are registered with the MHRA by the manufacturer or its UK responsible person. Under the UK MDR, UK approved bodies will operate in the same way as their EU counterparts, the notified bodies.