Ancillary medicinal substances

The European Medicines Agency (EMA) provides scientific opinions on the quality and safety of medicinal substances incorporated in medical devices that are liable to act upon a patient's body with an action that is ancillary (i.e supports) to the action of the device.

Directive 93/42/EEC and Directive Directive 90/385/EEC require notified bodies to verify the usefulness of a substance liable to have an ancillary action, and then seek an opinion from a competent authority. Full details of legislation covering medical devices are available from the European Commission.

Regulatory routes

  • If the substance is derived from human blood or human plasma - or falls under the scope of the centralised procedure - the notified body must consult EMA as the competent authority to issue a scientific opinion;
  • For other substances, the notified body and device manufacturer must choose a competent authority in a European Union (EU) Member State to issue a scientific opinion. They may also consult EMA, e.g. in cases where the Agency has already evaluated a medicine containing the same medicinal substance.

The notified body should give due consideration to the scientific opinion when making its certification decision.

Consultation procedure with EMA

For a new medical device, the notified body acts as the applicant 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 quality and safety are maintained. This is called a post-consultation procedure with EMA.

For further guidance on the procedures, see:

Consultation procedure - Q&A

1. Initial consultation

2. Post-consultation

3. Fees

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