[co-author: Vicky Vlontzou]
On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance, which may be considered to be a medicinal product, and which has action ancillary to that device. The guidance also refers to devices manufactured using Transmissible Spongiform Encephalopathy (TSE) susceptible animal tissues.
On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions on consultation of authorities regarding devices incorporating a substance, which may be considered to be a medicinal product and which has action ancillary to that device (including human blood derivatives).
The document is intended to provide guidance regarding the fulfillment of these consultation requirements for the first time under the MDR for devices that have already undergone a consultation with a competent authority or the EMA under the MDD and the AIMDD.
Consultation procedure under the MDD and AIMDD
The guidance recalls that the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) provide that for devices containing a substance, which, if used, would be considered to be a medicinal product and which is liable to act upon the body with an action ancillary to the device, the notified body is required to seek a scientific opinion from the competent authorities designated by the Member States or the European Medicines Agency (EMA).
Similarly, notified bodies are required to consult with the same authority when changes are made to that substance. This procedure is referred to as "supplementary consultation" in the guidance document.
The competent authorities and the EMA have 210 days from the receipt of all the necessary documentation to provide an opinion or 60 days for a supplementary consultation.
For medical devices containing a human blood derivative with ancillary action there is an equivalent consultation requirement. In this case, however, the notified body is required to consult the EMA only.
Transitioning from the MDD and AIMDD to MDR
According to the guidance a similar requirement for a consultation procedure is provided in the Medical Devices Regulation (EU) 745/2017 (MDR).
One substantial difference in the MDR procedure compared to that provided in the MDD and the AIMDD is that the notified body may not issue the certificate if the opinion is unfavorable.
Consultation for ancillary substances under the MDR for devices that have undergone the consultation under the MDD or the AIMDD
The guidance clarifies that a new consultation of a competent authority or the EMA is required under the MDR. For the first consultation under the MDR, the notified body is required to submit the full documentation package to the competent authority or the EMA.
This must include the last opinion of the medicinal products authority under the MDD or the AIMDD as well as a consolidated list of changes-if applicable- related to:
- 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; and/or
- The parts of the technical documentation related to the above aspects.
In cases where there have been no changes to the above, the package may be accompanied by a declaration of the notified body stating that the elements have remained identical.
The guidance also clarifies that it is up to the competent authorities to decide on the depth of their review if an opinion under the MDD/AIMD was already provided and the changes since last consultation remains limited. The guidance also provides that if many elements concerning the substance remain identical, the medicinal products authority is highly recommended to expedite its review.
Consultations for medical devices containing TSE susceptible animal tissue under the MDR
Article 5, paragraph 4, of Regulation (EU) 722/2012 regarding medical devices manufactured utilizing tissues of animal origin provides that for all medical devices, including active implantable medical devices, manufactured utilizing tissues of animal origin which are susceptible to TSE, the relevant notified body is required to seek an opinion from competent authorities and the European Commission.
Under the MDR this requirement remains unchanged.