BY COMPANIES
The process under the MDR for devices containing ancillary medicinal substances is largely unchanged, although the wording in Rule 14, no longer contains the phrase ‘liable to act’. The implications of this change of wording caused some concerns amongst industry and notified bodies alike as there was the potential for devices with ‘inactive’ medicinal substances to be upclassified. In fact, the correct interpretation of Rule 14 was clarified in MDCG 2022-5 (1).
This document clarified the interpretation of ‘ancillary action’ in the wording of Rule 14. In addition, the guidance also provided improved definitions of the terms pharmacological, immunological or metabolic and therefore an understanding of the borderlines between medicinal products and medical devices. One signification clarification was that the action could ‘take place in or on the human body or its constituents (e.g. blood, organs, in vivo or ex vivo, gametes, exudate from a wound) and supporting the device in achieving its specific medical purpose’. Therefore, substances having a medicinal effect ex vivo, for example in blood bags, are in scope of Rule 14.
For legacy devices, medical devices already certified under the Medical Device Directives (MDD), re-consultations for the ancillary medicinal substances were required as clarified in MDCG 2020-12 (2). Full documentation relating to the ancillary medicinal substance was required for this initial consultation along with a declaration from the notified body with respect to changes, if any, in the following:
- the ancillary substance
- its manufacturing process
- the way the substance is incorporated into the device
- design, manufacturing of the device which could influence the quality, safety or usefulness of the ancillary substance
- the parts of the technical documentation related to the above aspects.
Where there were no, or only administrative changes, it was anticipated reduced review times were possible. Indeed MDCG 2020-12 states “The medicinal products authority may consider the depth of its review given the extent of the changes since the previous consultation under the MDD/AIMDD. It is at the discretion of the medicinal products authority to issue its opinion in less than 210 days. If many elements concerning the substance remain identical, the medicinal products authority is highly recommended to expedite its review.” In reality, most reviews have taken closer to the maximum permitted time. The main causes for this were:
- Change of Competent Authority. For example, all consultations performed with the MHRA over the course of the MDD were required to be transferred to an EU Competent Authority because of Brexit. Although detailed reports from the MHRA were available, these applications were managed by the EU Competent Authorities as new applications.
- Changes to the device throughout the lifetime of the certificate. Significant changes or cumulative small changes may have resulted in a confused consultation history relative to the devices intended to be certified under the MDR.
- Updates to documentation including clinical evidence. Although guidance is available (3) the quality of Quality, pre-clinical and clinical documentation from device manufacturers is highly variable. Recently Competent Authorities have become stricter in terms of the adherence to the guidance resulting in new documentation and more thorough review.
- Competent Authority resource. Not all Competent Authorities are able to support the consultations set out in the MDR, leaving a small pool to support all the European NBs. This has led to long lead times and delayed reviews. Due to extensive discussions with the available CAs and forward planning of MDR Reconsultations, the majority of manufacturers with BSI have successfully completed this reconsultation process.
References
- MDCG 2022 – 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. [Online] April 2022
- MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured usi [Online]
- EMA/CHMP/578661/2010 rev .1 European Medicines Agency recommendation on the procedural aspects and dossier requirements for the consultation of the European Medicines Agency by a notified body on an ancillary medicinal substance or an ancillary human bloo [Online]
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