Fachthema Arzneimittel und Medizinprodukte fading v5

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. The topic is dealt with exclusively based on Union law and German law.

Fact sheets

13.03.2024

Medicinal products and medical devices

Fact sheets

Information about recall sites and food fraud

Retailer obligations for medical devices according to MDR

No results.

Articles

Current status of the Pharmacopoeia

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

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

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

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

Fact sheet on the classification of essential oils published

Revision of the guideline to the classification rules for in-vitro diagnostic medical devices

Current status of the Pharmacopoeia

Revision of the MDCG guideline for the standardisation of medical devices

Transitional period for condition for making medical devices available on the market for the first time ends soon

Current status of the Pharmacopoeia

Guidelines for the surveillance of medical devices with regard to transitional provisions of the MDR

New common specifications for in-vitro diagnostic medical devices to enter into force

Designation of technical standards for medical devices and in-vitro diagnostic medical devices

Revision of the MDCG template for the summary on safety and performance of in-vitro diagnostic medical devices

Current status of the Pharmacopoeia

Current status of the Pharmacopoeia

Harmonised standards for medical devices and in-vitro diagnostic medical devices published

Transitional period for conditions for making medical devices available on the market for the first time ends soon

Draft amendment to the MDR and further extension of the transitional periods of the IVDR

Current status of the Pharmacopoeia

Update of the Q&A on the obligations of importers and retailers of medical devices and in-vitro diagnostics

Transitional period of the German Pharmacopoeia ending soon

Provisional application of the European Pharmacopoeia, 11th edition, 3rd update

Master UDI-DI for contact lenses

Current status of the pharmacopoeia

Medical devices: Guidance on the application of the transitional provisions

RS virus tests for self-testing are now available over-the-counter

Update to Q&A of the EU Commission on the transitional periods for medical devices and in-vitro diagnostic medical devices

Harmonised standards for in vitro diagnostic medical devices

Harmonised standards for medical devices

Current status of the Pharmacopoeia

ECJ judgment on delimitation issues of medicinal products, food supplements and food for special medical purposes

Flu tests for self-testing are now available over-the-counter

Q&A of the EU Commission for the extension of the transitional periods for medical devices and in-vitro diagnostic medical devices

Facilitation planned for the award of the UDI for contact lenses

Further extension of the transitional periods for medical devices and in-vitro diagnostic medical devices

Current status of the Pharmacopoeia

Q&A document published on vigilance with medical devices

Transitional period of the German Pharmacopoeia expires soon

Application of the European Pharmacopoeia, 10 th edition, 7th update

Transitional period for the 5th update of the 10th edition of the European Pharmacopoeia ends soon

Defining joint specifications for in-vitro diagnostic medical devices

Application of the European Pharmacopoeia, 10 th edition, 6th update

Provisional application of the European Pharmacopoeia, 10th edition, 8th update

Regulation of the transitional period until EUDAMED is functional

Harmonised standards for in vitro diagnostic medical devices

Harmonised standards for medical devices

Harmonised standards for in vitro diagnostic medical devices

Harmonised standards for medical devices

Amendment to the German Pharmacopoeia

Provisional application of the European Pharmacopoeia, 10th edition, 7th update

Application of the European Pharmacopoeia, 10 th edition, 5th update

Extension and initial introduction of transitional periods for in vitro diagnostic medical devices

Transitional period for the 3rd update of the 10th edition of the European Pharmacopoeia ends soon

Harmonised standards for medical devices

Provisional application of the European Pharmacopoeia, 10th edition, 6th update

MDR date of application reminder

Deferring the date of application of the MDR

Amendment to the EU Medical Devices Directive and EU In Vitro Diagnostic Regulation

New regulations for medical devices and in vitro diagnostic medical devices

No results.