When a medical device incorporates a medicinal substance (as defined in Directive 2001/83/EC) which is liable to act upon the body with action ancillary to the device; the safety, quality and usefulness of the substance must be verified by analogy with the relevant medicinal products legislation as required by Annex I section 7.4 of the Medical Devices Directive (93/42/EEC).
To obtain CE marking for a product of this type the manufacturer must provide evidence for assessment by a notified body that the device conforms with the ‘essential requirements’ of Directive 93/42/EEC. The notified body must undertake a conformity assessment appropriate to the type of device and as defined, for example in Annex II section 4.3, must consult a competent authority for medicinal products in a member state before making a decision on its conformity assessment.
As the IMB is the competent authority for medicinal products in Ireland, a procedure has been established in order that a notified body can apply for a consultation such as that defined in Annex II section 4.3.
The objective of the consultation procedure is to verify the safety and quality of the medicinal substance, taking account of the intended purpose of the device, by analogy with the appropriate methods specified for medicinal products in Directive 2001/83/EC, as amended.
The IMB is currently in a position to accept applications for consultation from a notified body.
For further guidance regarding the procedural aspects of the consultation and dossier requirements, please see the IMB Guide to Drug-Device Consultations.
An application by a notified body for a consultation should be made using the IMB application form: Application for a Drug-Device Consultation.
If you require further information on the consultation process or have specific enquiries on the subject, please contact email@example.com.