Consultation for medical devices incorporating a medicinal substance

The Medical Products Agency (MPA), as a Competent Authority, may be consulted for verification of the safety, quality and usefulness of a medicinal substance in a medical device. The opinion given by the Competent Authority is to be taken into account by the Notified Body in the overall judgement of the medical device. 

Scope

The products concerned are medical devices that incorporate a medicinal substance as an integral part. The action of the medicinal substance should be ancillary to that of the device (e.g. bone cements containing antibiotic, blood bags containing anticoagulant etc.).

The Notified Body has the ultimate responsibility to decide whether the pertinent legal requirements for the product are met. To be able to make this decision a consultation with a Competent Authority to verify quality, safety and usefulness of a medicinal substance when this is an integral part of the medical device is necessary. The opinion given by the Competent Authority should be taken into account in the overall judgement made by the Notified Body.

The borderline between a medical device and a medicinal product together with the process for consultation is described in a guideline (Guidelines relating to the application of: The council directive 90/385/EEC on active implantable medical devices; the council directive 93/42/EEC on medical devices.

Actions to initiate consultation process

A request for consultation is made by a Notified Body by filling in the Request form (on this page) and submitting the form by e-mail (registrator@mpa.se) or regular mail to the MPA registrator (see contact information).

If a pre-meeting or a teleconference is requested, this should be specified in the formtogether with issues for discussion. The MPA will respond whether the assessment can be undertaken. If so the response will include information about when the MPA is prepared to receive the documentation and when the assessment can be finalised.

The time schedule is valid provided the documentation is submitted according to the agreed date. In case of delay, a new request must be done.

The consultation process

Within the MPA, a contact person will be appointed. A reference number is given to the Notified Body. In subsequent correspondence concerning this case, the reference number should be specified. When submitting the documentation for evaluation the application form (on this page) is filled in attached to the dossier. 

The MPA will assess the submitted documentation. In case of questions identified during the assessment, those will be sent as an assessment report to the Notified Body. After finalised assessment the MPA opinion will be sent.

An invoice will be sent to the Notified Body specifying the fee for the consultation, in accordance with the information in the table below.   

Drug /Device combination products – Consulation fees (SEK)

Classification	Fee1) (SEK)	Remark
New active substance (NCE) in SE	400 000	e.g. NCE in a new or established therapeutic area
Known active substance in a new therapeutic area	250 000
Known active substance in an established therapeutic area	150 000	e.g. a new stent with an active substance incorporated for which the MPA has previously been consulted
Variation - major	30 000	Major change which may affect quality of the active substance, safety or usefulness
Variation - minor	10 000	Minor change which may affect quality of the active substance, safety or usefulness

¹⁾only one fee will apply to multiple applications made at the same time for a range of similar drug/device combination products (e.g. a range of catheters made of identical material incorporating the same active substance in the same amount according to the same principle)