BY COMPANIES
One of the challenges for manufacturers and regulators alike is ensuring correct qualification of devices with respect to the different legislation. Common borderlines include medicines versus devices or devices versus cosmetics, especially since the introduction of Rule 21. Guidance is available, for example MDCG 2022-5, MDCG 2021-24 and the Borderlines Manual (1; 2); however, it is not possible to cover all scenarios in these guidelines. Note, the Manufacturer is responsible for the appropriate qualification of their product.
Important questions to ask to help determine the qualification and classification are:
- Are medical claims being made? Do these have appropriate clinical evidence (MDR Article 2(1))?
- Is the principal mechanism of action physical or pharmacological, immunological or metabolic? Is there evidence to support this?
- What claims are being made around the ingredients? Note if the manufacturer shows that the substance does not have any action ancillary to that of the device, no claims of benefits pertaining to that substance may be made on the IFU, labelling, packaging, advertising and websites.
A common area for additional scrutiny during the application stage is the use of constituents /ingredients which may also be commonly used in foods or cosmetics; when used in medical devices their action must be understood including any potential pharmacological, immunological or metabolic action. Examples include CBD or menthol. When ingredients could have an action on the body, for example anti-microbial or anti-inflammatory, evidence for the mechanism of action must be provided and their reason for inclusion in the formulation should be understood.
Where classification disputes cannot be resolved between a manufacturer and a notified body, Article 51(2) allows for the dispute to be resolved by the Competent Authority where the manufacturer resides (or their European Representative) and the Competent Authority where the notified body is located. At the current time, we have seen a limited number of cases that have required escalation via the arbitration process. The difficulty for those that have required arbitration is in the variability in the Competent Authority procedures and timelines. Potentially any European Competent Authority could be involved in the dispute process (based on manufacturer or EU representative); however, despite it being part of the regulation, not all Competent Authorities have a process in place to deal with such cases. In addition, the regulation does not clarify how the two Competent Authorities should communicate or give an overview on timelines. Our experience tells us this can add considerable time to a conformity assessment procedure.
Conclusions
The aim of the MDR was to improve and future proof the regulatory framework for medical devices in the EU and improve the Integral Drug-Device Combinations assessment process by involving device expertise to the process, with increased patient safety at the core. The MDR has strengthened the cooperation across differing specialisms, with Notified Body’s now part of the assessment process for Integral Drug-Device Combinations, while Medicine Competent Authorities continue to support NBs in the assessment of medical devices with ancillary medicinal substances, whilst also introducing the involvement of Medicine Competent Authorities in the assessment, where necessary, for Substance Based Medical Devices.
Combination Products continue to be an important area of growth, with Integral Drug-Device Combinations offering many innovative solutions to assist self-care at home and improve patient compliance for medications. Device-Drug Combinations continue to support the use of the device and provide state of the art healthcare solutions.
For substance-based devices the inclusion of a specific rule within the MDR was necessary to ensure appropriate scrutiny given the particular challenges and risks associated with devices having this level of invasiveness, potential toxicity and the potential self-care nature of these products.
What we have learnt during the implementation phase of the MDR is the importance of continued dialogue between all stakeholders to work together to provide additional clarification on requirements and expectations and to increase harmonisation in expectations.
References
- Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022). [Online]
- MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019). [Online]
