How to keep your compass when navigating Medical Devices Regulations?

The Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) introduced significant changes to the regulatory framework for medical devices (MD), including more rigorous pre-market evaluation and post-market surveillance requirements.

Understanding the governance of this regulatory system allows manufacturers and other economic operators:

• To determine their obligations and responsibilities, such as the need to engage with Notified Bodies (NB) for conformity assessment and to maintain appropriate technical documentation for their devices.
• To participate effectively in the new regulatory system, including engaging with relevant authorities and contributing to the development and implementation of guidance documents and standards.

1/ Setting your Course - Mapping out your MDR/IVDR journey!

Since the adoption of the two Regulations, the governing bodies of the regulatory system put a stronger focus on harmonising rules in the fields of MDs and IVDs throughout the European Union (EU). Competent authorities¹, expert panels² and the MDCG (Medical Device Coordination Group) interact to shape regulatory requirements and create guidance for the market. Understanding this complex and evolving governing environment is necessary to navigate through the new MD life cycle without risk.

Figure 1: Governance of the medical devices regulatory system

The new Regulations created the MDCG and MDSSG and gave existing governing bodies new responsibilities in the field of medical devices. These governing bodies aim to ensure patient safety, maintain competitiveness, and develop innovation in the internal market through the implementation of new Regulations related to medical devices.

1. The MDCG, along with its 13 subgroups, is a newly formed coordination group that provides technical, logistic, and scientific support to ensure cooperation between national competent authorities.
2. The EMA provides scientific and technical advice to support the work of the European Commission and national competent authorities in the implementation of the Regulations and gives guidance on the evaluation of applications for CE certificates by notified bodies. It also supports the scientific assessment of certain medical devices (e.g., borderline medical devices).
3. From February 2023, the new Medical Device Shortages Steering Group (MDSSG) reinforces the role of EMA in the surveillance of risks of shortages. It monitors medical devices' demand and supply within the EU, establishes a list of medical devices critical for public health, and issues recommendations in case of shortage from several stakeholders in the industry (Art. 23/24, EU 2022/123).
4. The CAMD enhances cooperation between all European competent authorities by capacity building with the different stakeholders (Notified bodies, Experts, MDCG working groups, etc.) and sharing best practices during the Regulations’ transition phase.
5. The HMA ensures that Regulations and the long-term development of regulatory systems are consistent with economic operators' activities and provides insights to economic operators to improve the understanding of the Regulations.

Figure 2: Medical devices regulatory governance framework

Governing bodies collaborate closely to ensure coherence in the regulatory framework for medical devices. However, economic operators, patients, and healthcare professionals (HCPs) are finding challenging to navigate the complex regulatory landscape. To ensure regulatory impact on the decision-making processes, these stakeholders depend on the national and EU Level representatives, sitting and/or represented in the governing bodies. They can also provide direct feedback via the frequent consultations organised by the European Commission on the 'Have your say' Portal.

2/ Keep your compass – Navigate your way through the new MD regulatory lifecycle!

The new Regulations led to fundamental changes in the life cycle of a medical device. The previous regulatory framework had not always been in sync with the progress, innovation, and market access of medical devices. Under the former Medical Device Directive (MDD), crucial aspects of the CE Marking were omitted leading to the establishment of the current Regulations which establish more stringent requirements around clinical evidence, surveillance, traceability, quality assurance etc.

MDCG’s 13 subgroups³ closely oversee the phases before and after the CE marking of medical devices, including a dedicated sub-group for in-vitro medical devices.

Figure 3: Medical Device regulatory lifecycle

The Pre-CE marking phase covers the design and the development of the device. During this phase, several areas of the product registration process are supervised by the following sub-groups:

• Borderline issues and new technologies: the new Regulations provide a refined classification of medical devices, IVDs and in-house devices based on harmonised standards to increase the accuracy of the required clinical evaluation and minimise potential risks for patients. In the case of aesthetic and non-medical products, common specifications serve as technical and clinical requirements to meet legal obligations. Categorising novel technologies to ensure patient safety while promoting innovation is a balancing act and focuses on focuses on new software, applications, and artificial intelligence (AI).
• Improved clinical evidence: the Regulations mandate stricter clinical investigation, evaluation, and quality management to ensure the safety and efficacy of the device. It includes a more robust assessment of MD performance for instance through stricter evaluation for high-risk devices with expert panels and EMA or through the coordination of multi-centric studies across the EU.

The CE Marking Approval: Notified bodies undergo more rigorous designation standards with experts’ involvement than under the previous Directives to maintain consistent EU-wide regulation. Notified bodies ensure harmonised conformity assessments and that certified medical devices are readily available for the smooth functioning of the market.

The post-CE marking phase includes the manufacturing process and the device’s market access. The new Regulations also enhance the product surveillance process:

• Systems and convention: to allow enforced traceability, Unique device identification (UDI) and Nomenclature designation are new requirements for economic operators. Furthermore, the European publicly accessible database on medical devices, EUDAMED, increased transparency and is predicted to boost EU competitiveness by highlighting synergies and improving mutual learning between EU Member States.
• Surveillance and monitoring: to maintain a high level of protection of health for patients, market and post-market surveillance and vigilance are central activities in these new Regulations. The exchange of information between governing bodies of Members States is predicted to improve the risk assessment and performance follow-up of medical devices on the market. Critically important for patient safety, incidents management and reporting are core features of the new regulatory framework.

Additionally, the governing bodies keep track of global regulatory trends and collaborate closely with the International Medical Device Regulators Forum (IMDRF).

The recent implementation of the Regulations created a significant impact on the medical technology industry, national authorities, and most importantly, HCPs and patients. The success of these Regulations will greatly depend on the ability of the industry to transition and adapt smoothly to the new rules, as well as the efficiency of the authorities in providing regulatory oversight and enforcement. The stakes are high, and it is crucial for all parties involved to work together to ensure that patient safety remains the top priority and that the Regulations are implemented efficiently.

In our next article about MDR/IVDR, we will dig deeper into the challenges and difficulties encountered by industrials, specifically small and medium-sized enterprises (SMEs) and very innovative companies, to comply with the new regulatory framework and the strategy undertaken to mitigate risks associated to the overall CE Marking process for their business and for patient access.

Endnotes:

1. (e.g., HMA: Heads of Medicines Agencies; CAMD: Competent Authority for Medical Devices or EMA: European Medicines Agency)
2. Expert panels shall consist of advisors appointed by the Commission on the basis of up-to-date clinical, scientific or technical expertise in the field and with a geographical distribution that reflects the diversity of scientific and clinical approaches in the Union.
3. The IMDRF and IVDs sub-groups are not represented in this graph, as the first one takes charge of international cooperation and the second one covers a lot of the responsibilities similar to these subgroups dealing with medical devices.

Authors:

• Corinne De Villeneuve, Director Life Sciences
• Mathieu Capdevila, Director EU
• Agathe Maoui, Manager Life Sciences
• Arnauld Seux, Consultant Life Sciences
• Pamela Barhouche, Consultant Life Sciences