The MDCG issued a Guidance on the conformity assessment procedure for special category of devices as per the Article 52 of the MDR:
‘‘for devices incorporating, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which has an action ancillary to that of the device”
In such cases, the Notified Body is required to consult a medicinal products authority designated by a Member State or the EMA on the quality and safety of the substance, including the benefit or risk of the incorporation of the substance into the device.
It has to be precised that the Guidance addresses specifically the requirements for those devices that already underwent a consultation with a medicinal products’ authority according to the Directives.
The MDCG nevertheless reminds that any Notified Body issuing a MDR Certificate shall carry out a full conformity assessment covering all requirements under the MDR, including consultation process under Article 52 (9), even if the device has been certified under the MDD. Even in cases, where there are no changes to the device itself, there may be changes in the documentation in view of the new MDR requirements, ”for example in clinical evaluation, which have a bearing on the quality, safety or usefulness of the ancillary substance.”
For the first consultation under the MDR, as per the MDCG, the Notified Body is required to submit the full documentation package to the medicinal products authority (of its choice), and include the last opinion of the medicinal products authority under the Directives, as well as a consolidated list of changes of:
• 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.
The Notified Body may accompany the documentation with a statement that the elements have remained identical, if there were no changes to some or any of the elements of the above list.
In view of the changes, it is up to the medicinal products authority to decide on the depth of the review and to issue an opinion in less than 210 days. Nevertheless, the MDCG proposes to speed up the review in case of identical substances.
Moreover, the MDCG emphasizes that for the devices where “liability to act upon the body” was used by the manufacturer as a justification not to follow the consultation, the consultation must take place under the MDR.”
The MDCG also touches upon devices containing TSE susceptible animal tissue under Annex IX Section 5.3.2 of the MDR. It states that during the first certification under the MDR, the Notified Body shall submit
”the full summary evaluation report as stated in Regulation (EU) 722/2012 to the competent authorities.”
The Notified Body may accompany the documentation with a statement that the elements have remained identical, if there were no changes to the documentation required from the manufacturer as per the Regulation (EU) 722/2012. In case of administrative changes, these should be clearly detailed in the documentation.