Consultation procedure for ancillary medicinal substances in medical devices
Regulation EU 2017/745 requires notified bodies to seek an opinion from a competent authority on the quality and safety of medicinal substances incorporated in medical devices that have an action that is ancillary (i.e supports) to the action of the device. The notified body should give due consideration to the scientific opinion when taking its certification decision.
The European Medicines Agency (EMA) is the competent authority for substances derived from human blood or human plasma or that fall under the scope of the centralised procedure. Notified bodies may also consult EMA for other substances e.g. if the Agency has already evaluated a medicine containing the same active substance. For more information on medical devices with ancillary medicinal substances, seeMedical devices.
For a new medical device, the notified body acts as the applicant on behalf on device manufacturer in an initial consultation procedure with EMA. It should provide an 'intention to submit' letter, preferably at least six months before it expects to submit the application. Further details are available in the questions and answers (Q&A) and the guidance documents below.
When changes are made to an ancillary substance for which EMA has already given an opinion, in particular to its manufacturing process, the notified body should consult the Agency to confirm that quality and safety are maintained. This is called a post-consultation procedure with EMA.
For further guidance on the procedures, see:
- Medical Devices Guidance document (MEDDEV)
- 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 (June 2020)
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EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 1 (PDF/304.7 KB)
Adopted
First published: 21/01/2020
Legal effective date: 21/01/2020
EMA/CHMP/578661/2010 Rev .1 -
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Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device (PDF/217.82 KB)
First published: 14/12/2015
Last updated: 31/07/2023
EMA/144066/2021 Rev. 2 -
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Application form for consultation by a notified body on an ancillary medicinal substance/ancillary human blood or plasma derivative used in a medical device (DOC/302.5 KB)
First published: 27/02/2012
Last updated: 30/03/2021
EMA/75225/2020 -
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Application form for a post-consultation procedure on an ancillary medicinal substance in a medical device (DOC/174 KB)
First published: 27/02/2012
Last updated: 30/03/2021
EMA/75252/2020