Scope of the MDCG Guidance
The new MDCG guidance describes the way that transitional provisions should be applied with regard to medical devices containing medicinal substances providing ancillary actions. The scope of the document pertains to medical devices that contain animal tissues. The document is intended to assist regulating authorities and notified bodies in applying the appropriate regulations.
Medical devices that fall within the scope of the present MDCG guidance are subject to regulation under the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). In accordance with the aforementioned regulation, if a medical device in question contains a substance that could be determined as a medicinal product (and such substance provides ancillary action), the notified body performing the conformity assessment of such a device shall contact competent authorities in order to obtain a scientific opinion. Such scientific opinion should cover all aspects related to the compliance of medicinal products subject to review with applicable safety and performance requirements. It should also cover an assessment of the impact that the substance makes to the benefit/risk profile of the medical device as a whole. If any changes are made to the ancillary substance after the initial registration of the medical device, the notified body will have to request an additional expert opinion regarding the impact of such changes.
According to the MDCG guidance on medical devices with ancillary substances, the notified bodies should consult with the European Medicines Agency (EMA) and other competent authorities regarding any issues related to medicinal products included in the conformity assessment.
Transitional Provisions: from MDD and AIMDD to MDR
The document also describes the way regulations should be applied in the context of the ongoing transition from the Directives to the new Medical Devices Regulation 2017/745 (MDR). The MDR contains appropriate provisions requiring the notified body to consult with competent authorities regarding the usefulness of the ancillary substance that the medical device in question contains. The same applies to any cases concerning Directives as notified bodies shall first consult with the EMA (or another competent authority). This should be done during the initial conformity assessment of the medical device containing medicinal products that have ancillary action, as well as in case of any changes made to such medicinal products. According to the MDCG guidance, the following timeline should be applied for the response:
- In the case of the initial request, the EMA (or another competent authority) shall provide the motivated response within 210 days from the day that materials were received from the notified body,
- In the case of supplementary consultation, the competent medicinal products authority shall provide its response within 60 days.
The MDCG additionally emphasizes the important novelties implemented in the MDR: under the new framework, the notified body is allowed to issue a certificate only if a positive opinion is received from the competent products authority regarding the ancillary substance.
Rules for Previously Registered Medical Devices
First of all, it is important to mention that in accordance with the MDCG guidance, in the course of issuing a certificate under the MDR, the medical device containing an ancillary substance should be subject to an additional conformity assessment even if it has already been assessed under the Directives. Thus, additional consultation with the competent products authority will be required. The MDCG also states that if no significant changes are made to the medical device itself or the manufacturing process, the additional assessment would be required due to changes to the documentation set forth under the new Regulation. For example, documentation regarding clinical evaluation shall cover aspects related to safety, quality, and usefulness of the medicinal products that the device contains.
In order to be able to carry out the conformity assessment of the medical device containing an ancillary substance, the notified body will require the full set of information and documentation including those related to the medicinal product that the device contains. The notified body is also allowed to contact any competent medicinal products authority since there is no requirement to consult exclusively with the particular authority that performed the assessment during the initial certification of the device. The notified body shall also require the medical device manufacturer to provide a consolidated list of changes to the medical device, including ones to:
- The medicinal product (ancillary substance) the device contains,
- The manufacturing process,
- The composition of the device,
- The design of the device itself (in the part impacting the safety or usefulness of the ancillary substance),
- Technical documentation describing the aforementioned aspects.
If some of the aspects remain unchanged, the medical device manufacturer shall submit the appropriate declaration. At the same time, if any administrative changes take place, they shall also be covered by the declaration.
According to the MDCG guidance, the complexity of the assessment to be performed and the time necessary to perform such an assessment is dependent on the significance of any changes made to the medical device containing the ancillary substance. The MDCG states that in case any changes were insignificant, the authority would be allowed to issue its opinion earlier.
MDCG’s Additional Rules for Medical Devices Containing Ancillary Substance
The present MDCG guidance also describes additional rules to be applied in case the medical device contains medicinal products (ancillary substance). In particular, the document outlines specific changes to the regulatory framework implemented by the MDR.
In accordance with the new regulatory requirements, medical devices falling within the scope of the “liability to act upon the body” would be subject to a mandatory consultation as well. The same approach should be used in case of any doubts: in all cases, if it is unclear whether a consultation with the competent authority is needed, such consultation shall be performed.
MDCG’s Additional Rules for Medical Devices Containing Animal Tissue
The scope of the MDCG guidance also discusses specific types of medical devices, especially those containing tissues of animal origin. According to the document, if the medical device in question contains tissues of animal origin, which are susceptible to transmissible spongiform encephalopathy (TSE), a consultation with the competent authority will be needed. In accordance with the general procedure, all medical devices of this type should be subject to additional consultations in the course of a conformity assessment under the MDR. At the same time, with regard to changes to the device, the same general rules could be applied. If no changes were made to the medical device subject to review, the appropriate declaration would suffice.
Summarizing the information provided hereabove, the present MDCG guidance describes procedures that notified bodies shall follow when carrying out the conformity assessment of medical devices containing medicinal products (ancillary substances) or animal tissues.
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