Since 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) has applied. The regulation repealCouncil Directives 90/385/EEC (MDD).
According to MDCG Guidance 2020-12, all medical devices with an ancillary medicinal substance (a.k.a. “drug-device combination products”) which have been marketed in the EU under MDD have to be submitted to a medicines agency, either a national competent authority or the European Medicines Agency, to obtain a scientific opinion on the pharmaceutical part of the combination product. Based on the scientific opinions, the notified bodies can issue a certificate under the new regulation.
Below you will find a list of national competent authorities that can perform the consultations in question.
National Competent Agency
STA.meddev@ fagg-afmps .be
blanka.hirschlerova@ sukl .cz
Gabriele.Eibenstein@ bfarm .de
innovation@ pei .de
med-udstyr@ dkma .dk
combiprod@ aemps .es
anne.driheme@ ansm.sante .fr
inter.rel@ eof .gr
info@ hpra .ie
medicaldevices@ cbg-meb .nl
monika.oracz@ urpl.gov .pl
infarmed@ infarmed .pt
dgdm@ anm .ro
registrator@ lakemedelsverket .se
Notes on areas of special interest:
- AIFA (IT) provides "scientific opinion" for class III medical devices containing medicinal substances with ancillary function to the Notified Body O373 located at the public institution "Istituto Superiore di Sanità" (ISS - Italian National Institute of Health). The service provided by AIFA is regulated by an agreement between public institutions. Conversely, there are currently no procedure/fees that regulate the relationship between AIFA and other private Notified Bodies. Discussions are ongoing to manage this activity as well. In conclusion, the publication of a list of ancillary medicinal substances/devices for AIFA is not currently possible.
- SÚKL (CZ) can provide consultations in all therapeutic areas. The agency has in particular experience with tacrolimus-eluting stents.
- PEI (DE) specific focus areas are Antibodies, Blood Products, ATMPs, Tissues and Cells, Vaccines, Allergens
- MAA (MT) is setting up a unit to consult drug-device combination products and the agency. In continuation hereof, the agency is open to receive queries on request.