Fachthema Arzneimittel und Medizinprodukte fading v5

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Medicinal products and medical devices

This topic includes product-specific information on the following product groups:

over-the-counter (OTC) medicines, health products

Medicinal products and medical devices are both product groups with a medical purpose. While medicinal products always contain an active substance, medical devices also include items like wound dressings, reading glasses or condoms. In vitro diagnostics like Corona self-tests are also considered to be medical devices.
In this topic, you will find information on medicinal products and medical devices that are available over-the-counter, i.e. that do not require a prescription or a pharmacy.

Fact sheets

23.07.2025

Medicinal products and medical devices

Fact sheets

Instruction manual for medical devices

Labelling of medical devices

Information about recall sites and food fraud

Retailer obligations for medical devices according to MDR

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Articles

Current status of the pharmacopoeia

Deadline for product registration in Eudamed is approaching

Designation of technical standards for medical devices and in vitro diagnostics

Usage of the Master UDI-DI for contact lenses becomes mandatory

Consultation on the revision of the Therapeutic Products Act

Appendix to the guideline for the standardisation of medical devices published

Transition period for Class C in vitro diagnostic medical devices ending soon

Publication of new and revised harmonised standards for medical devices

Publication of an updated harmonised standard for in-vitro diagnostics

Current status of the pharmacopoeia

Update of the guidance on the implementation of the Master UDI-DI for spectacles

New version of the FAQ document on the European Medical Device Nomenclature

Manual on borderline and classification for medical devices updated

Guidance on classification of medical devices has been updated

Publication of harmonised standards for medical devices

Update of the Q&A on information obligations in the event of interruption or termination of the supply of medical devices

Current status of the pharmacopoeia

Entries on fennel as a traditional herbal medicine have been updated.

Use of Eudamed will soon become mandatory

Transition period for class C in vitro diagnostic medical devices is ending soon

Relief measures planned in medical device law

Publication of harmonised standards for in vitro diagnostics

Publication of harmonised standards for medical devices

Guidance on Post-Market Surveillance of In Vitro Diagnostics and Medical Devices

Publication of an MDCG guideline on the introduction of the Master UDI-DI for spectacles

Position paper of the MDCG on the Master UDI-DI updated

The current status of the pharmacopoeia

Use of Eudamed becomes mandatory

Publication of harmonised standards for medical devices

Introduction of the Master UDI-DI for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles

Manual on Borderline and Classification for Medical Devices Updated

Current status of the pharmacopoeia

MDCG guidance on the introduction of the Master UDI-DI updated

Master UDI-DI for contact lenses mandatory only from 2026

MDCG position paper on the introduction of the master UDI-DI

ECJ judgement on organic logo for medicinal teas

FAQ on the interaction of MDR, IVDR and AI Act published

Guideline for the qualification and classification of software according to MDR and IVDR revised

Amendment of the requirements for electronic instructions for use for professional medical devices

Current status of the Pharmacopoeia

Transition period for in-vitro diagnostics ends soon

New helpdesk for the European Medical Device Nomenclature (EMDN)

Publication of harmonised standards for the sterilisation of in vitro diagnostic medical devices

Publication of harmonised standards for disposable medical gloves and the sterilisation of medical devices

New version of the MDCG guideline on classification rules for in vitro diagnostics published

Current status of the Pharmacopoeia

Draft amendment to the electronic instructions for use for professional medical devices

Transition period for in-vitro diagnostics ends soon

UDI labelling for certain medical devices and in-vitro diagnostics becomes mandatory

Transition period for in-vitro diagnostics ends soon

Amendment to the Medical Devices Dispensing Ordinance

Draft for the introduction of a master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading glasses

New version of the guide and FAQ document on the European Nomenclature for Medical Devices

Publication of a recommendation on the classification of SARS-CoV-2 tests

EUDAMED Information Centre

Second revision of the Q&A document on vigilance for medical devices and in-vitro diagnostic medical devices published

Form for information on interruptions in the supply of medical devices and in vitro diagnostics

Current status of the Pharmacopoeia

Publication of an MDCG guideline for the introduction of the Master UDI-DI for contact lenses

Publication of a Q&A document on practical aspects of the phased commissioning of EUDAMED

New version of the Q&A document on vigilance for medical devices and in-vitro diagnostic medical devices published

Current status of the Pharmacopoeia

Q&A on the extended transition periods for certain in vitro diagnostic medical devices

MDCG guidance on the regulatory status of ethylene oxide for sterilisation of medical devices

MDCG guideline on the distinction between medical devices and medicinal products updated

Q&A on information obligations in the event of interruption or termination of the supply of medical devices

Amendment of the Medical Devices Act Implementation Act

Further extension of the IVDR transitional periods, commissioning of EUDAMED and information obligations

New version of the MDCG guideline on the application of the transitional provisions of the MDR published

Harmonised standard for the aseptic manufacturing of healthcare products published

MDCG guideline on the qualification of in-vitro diagnostics published

Draft adaptation of the joint specifications for class D in vitro diagnostic medical devices