Devices incorporating a Medicinal product or devices manufactured using TSE susceptible animal tissues: Transition from MDD/AIMD to MDR

UNDER MDD/AIMDD YOU MIGHT NOT HAVE NEEDED A CONSULTATION- UNDER THE MDR, HOWEVER THIS MIGHT BE DIFFERENT

A. Medical Device incorporating a medical substance

In order to be able to fulfill requirements for the first time under the MDR, even if your device has already underwent a consultation with a medicinal products authority according to Annex I 7.4 of the MDD or Annex I 10 of the AIMDD you should be aware of the following:

• MDR, similar to MDD or AIMDD, if the device incorporates, 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 the NB is required, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, 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 (Article 52 (9) (Annex IX section 5.2 and Annex X Section 6): .

A big difference, with the MDD/AIMDD is, that MDR states that the NB may not deliver the CE MARK certificate if the opinion from EMA or medicinal products authority is unfavourable (Annex IX 5.2 (e) and (f)).

• MDD: Annex I 7.4 of the MDD refers to devices in which the substance is liable to act upon the body. The MDR, however, (Article 52(9), referring to Article 1(8), and Section 5.2 of Annex IX), this is no longer the case. Therefore for all those devices where the "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.

In those cases where there are doubts on the applicability of the consultation, the notified body should seek the scientific opinion as described in Annex IX Section 5.2 (b) of the MDR

YOU MUST THEREFORE CLEARLY DEFINE, A HEAD OF TIME, IF YOUR DEVICE NEEDS A CONSULTATION OR NOT UNDER THE MDR. The fact, that under the MDD/AIMDD you did not need a consultation, does not mean your device will not need one.

• For the first consultation under the MDR, the NB is

1. Required to submit the full documentation package to the medicinal products authority as described in dedicated guidance.
2. Free to approach any medicinal products authority at its discretion, not necessarily the one consulted under the MDD/AIMDD.

• The medicinal products authority may contact the authority consulted on this device under the MDD/AIMDD, who may, at its discretion, confirm the opinion provided in the previous consultation and/or share any additional information

B. Medical Device incorporating a TSE susceptible animal tissue

Under the MDR (Annex IX Section 5.3.2), the requirement as set out in Art 5(4) of Regulation (EU) 722/2012 remain unchanged .

Therefore, during the first certification under the MDR, the NB is required to submit the full summary evaluation report as stated in Regulation (EU) 722/2012 to the competent authorities. If there have been no changes to the documentation required from the manufacturer as per Regulation (EU) 722/2012, the summary evaluation report may be accompanied by a declaration by the notified body to this effect, stating the elements that have remained identical. If there have also been no changes to the assessment of this documentation by the notified body, this may also be included in the declaration. Should there be only administrative changes to the above (e.g. changes of names or addresses, changes in document layout, etc.), these should be clearly detailed in the declaration.

Reference:

1. Regulation (EU) 2017/745
2. Regulation (EU) 722/2012- Requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
3. 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 using TSE susceptible animal tissues