Comparision between pharma­ceuticals and medical devices

Both pharma­ceuticals and medical devices have an intended medical purpose. Some components of medical device can also be on the market as components of cosmetics and pharma­ceuticals.

According to the "Guidelines Relating to the Application of The Council Directive on Medical Devices" (MEDDEV 2. 1/ 3 rev 3, A.2) the intended purpose and product advertising, on the one hand, and and the mode of action, on the other hand, have to be considered.

Pharma­ceutical Medical device
Mode of action
(Main effect)		 pharmacologic
immunological
metabolic		 mechanical
physical
chemical
physicochemical
Legal foundations Germany
AMG (medicines law) and regulations

Europe
Regulation (EC) No. 726/2004 		Germany
MPG (medical devices law) and regulations

Europe
Medical devices:
CD 90/385/EEC and CD 93/42/EEC
on 2020-05-26 superseded by Regulation (EU) 2017/745 (MDR)

In vitro diagnostics devices:
CD 98/79/EC
on 2022-05-22 superseded by Regulation (EU) 2017/746
Authorisation Clinical investigation

Centralised Procedure (CP) of the European Medicines Agency (EMA)

Decentralised Procedure (DCP) / Mutual Recognition Procedure (MRP) in some EU states

National procedures 		Clinical evaluation of literature based clinical data and experience or clinical investigations

Conformity assessment (CE certification)
Post access/market surveillance Phase IV
PAES & PASS
Non interventional (NIS, epidemiological studies)
Register 		PMCF studies
German regulations on combinations:
  • Medical devices with a pharma­ceutical as component, that has an auxiliary function:
    The whole product is regulated by the MPG (The pharma­ceutical has to be approved separately).
  • Medical device and pharma­ceutical form one unit, eg. a pre-filled syringe:
    The whole product is regulated by the AMG (The medical device has to fulfil the regulations on medical devices).
  • Medical device for the administration of a pharma­ceutical, eg. an insulin pump, that is separately included in the package:
    The medical device is regulated by the MPG and the pharma­ceutical is regulated by the AMG.
References