MDCG issues guidance on transitioning devices with ancillary substances to MDR
The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance explaining the process for transitioning CE certificates for devices containing an ancillary substance that could be considered a medicinal product or those manufactured using animal tissues under the Medical Devices Regulation (MDR).The document also explains some of the differences in requirements and consultations from previous legislation.
Ancillary substances
Under both the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) and the MDR, medical devices that incorporate an ancillary substance that could be considered a medicinal product, such as a drug or human blood derivative, must undergo a consultation with a medicinal product authority or the European Medicines agency (EMA), “On the quality and safety of the substance in the medical device, including the clinical benefit-risk profile of the incorporation of the substance into the device.” Supplementary consultations are also required to review changes to the substance or its manufacturing process to ensure those changes do not negatively impact the benefit-risk profile of the device.
While the process is similar under the MDR, there are some changes, including a 210-day timeframe for the competent authority or EMA to provide an opinion for initial consultations and a 60-day window for supplementary consultations.
The MDR also explicitly states that notified bodies may not issue a certificate if the opinion is unfavorable.
As with other devices, notified bodies must complete a full conformity assessment for the device before issuing its first certificate under the MDR. However, for devices containing ancillary substances, MDCG says this requirement, “Includes the consultation of the medicinal products authority,” under Article 52(9) of the MDR.
While the guidance acknowledges there may have been no changes to the device or the ancillary substance since its last consultation, “Nevertheless, there may be changes in the documentation of the device due to the new requirements of the MDR, for example in clinical evaluation, which have a bearing on the quality, safety or usefulness of the ancillary substance,” or new information about the substance available to the medicinal products authority that could influence its opinion.
For an initial consultation under the MDR, MDCG says that notified bodies must “submit the full documentation package to the medicinal products authority,” and notes that the notified body may seek a consultation from any medicinal products authority it chooses, which does not have to be the same one consulted under the MDD/AIMDD.
The documentation package should include the previous opinion for the ancillary substance and a consolidated list of changes. Notified bodies may also include a declaration stating whether there were changes made pertaining to the ancillary substance, the notified body’s assessment of the product or whether only administrative changes were made.
The guidance states that the medicinal products authority “may consider the depth of its review given the extent of the changes since the previous consultation,” and recommends that medicinal products authorities expedite their review “if many elements concerning the substance remain identical.”
Animal tissue
For devices manufactured using transmissible spongiform encephalopathy (TSE) susceptible animal tissues, the MDR requires notified bodies, via their competent authority, to “carry out a consultation of the other competent authorities and the Commission.”
This requirement is unchanged from Regulation (EU) 722/2012.
For notified bodies, the first certification under the MDR for such devices requires the submission of a complete summary evaluation report to the competent authorities.
As with devices incorporating ancillary substances, declarations may be included to note whether certain elements are unchanged from the previous consultation.