MEDiLEX: The interactive reference work for European medical device law.

MEDiLEX bundles the complex EU legislation for medical devices and in-vitro diagnostics in a networked, digital work. The content is available in archived form.

Search contents

MEDiLEX: The interactive reference work for European medical device law.

MEDiLEX bundles the complex EU legislation for medical devices and in-vitro diagnostics in a networked, digital work. The content is available in archived form.

Search contents

What is MEDiLEX?

MEDiLEX is an interactive reference work for European legislation on medical devices and in-vitro diagnostics. All relevant documents in one work, logically interlinked and accessible via an integrated full-text search. The archived content is still available for viewing.

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Complete

All relevant EU documents on MDR and IVDR in one work.

Networked

Numerous cross-references make content-related references directly visible.

Quick

Full text search leads directly to the text passage you are looking for.

Digital

Can be used directly in the browser, without installation.

Still have questions? Please contact uswe know the answer.

How MEDiLEX supports you in everyday life

Asking regulatory questions

You are working on a conformity assessment procedure and need the exact requirement from MDR or IVDR.

Use full text search

The integrated search function takes you directly to the relevant text passage without having to go through tables of contents.

Cross-references follow

Linked documents immediately show all relevant contexts, standards and implementation acts.

Use MEDiLEX directly in the browser

Note

MEDiLEX is no longer actively updated. The archived content is still available, but may no longer be fully up-to-date. Please check regulatory relevant information against current official sources.

MEDiLEX

Frequently asked questions

International market approval raises many questions. We have answered the most common ones for you – from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Your question is not listed? Please feel free to contact us.

What does MEDiLEX contain?

All relevant documents on European legislation on medical devices (MDR) and in-vitro diagnostics (IVDR), complete, networked and continuously updated.

Who is MEDiLEX suitable for?

MEDiLEX is aimed at professionals who regularly work with the European regulatory framework for medical devices and IVDs.

How does MEDiLEX differ from printed works?

Cross-references link documents directly, content is constantly updated and the full-text search enables targeted research. This is not possible with a printed work.

Is MEDiLEX still being updated?

MEDiLEX is currently no longer actively maintained. The existing content is still available for viewing, but can no longer fully reflect the current status of European legislation. For binding regulatory searches, we recommend using the official sources of the EU Commission as a supplement.

Alfred Koch

CEO | PRRC

How to contact us

Are you planning a project or do you have very specific regulatory questions about placing your medical device on the market? No matter what phase of your project you are in, we will be happy to support you. The quickest way to reach us – feel free to write to us.