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Latest NEWS: Swissdamed delayed to second half of 2024 +++ Latest DOCUMENT in our Library: Medical technology industry perspective on the final AI Act (MedTech Europe) +++ Manufacturer self-declaration for legacy devices in STORE now +++ WEBINAR on MHRA step by step registration +++ Our memberships give access to our comprehensive Library of documents, immediate regulatory alerts,...
Latest NEWS: Swissdamed delayed to second half of 2024 +++ Latest DOCUMENT in our Library: Medical technology industry perspective on the final AI Act (MedTech Europe) +++ Manufacturer self-declaration for legacy devices in STORE now +++ WEBINAR on MHRA step by step registration +++ Our memberships give access to our comprehensive Library of documents, immediate regulatory alerts,...

We make European MDR and IVDR

Did you know that QMS as per ISO 13485:2016 requires to have a system in place to monitor relevant regulatory requirements and related changes ?
MDlaw offers exactly such system!
Find all Medical Device Regulation related documents in 1 place – news, legislation, guidelines, templates and more!
MDlaw explained in 1 minute - click here!

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Purchase checklists, guidance and (gap) analysis documents on MDR & IVDR. Publications are produced by the experts in the sector to help you comply with the legal requirements.

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NATIONAL REQUIREMENTS FOR MEDICAL DEVICES (MDR)

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    UNITED KINGDOM

    Great Britain is not applying MDR. Northern Ireland, however, is. More information will be provided soon.

    DENMARK

    MDR implementing law has been published & is available on MDlaw. Click here to learn more.

    NETHERLANDS

    MDR implementing law has been published. Click here to learn more.

    IRELAND

    MDR implementing law has been published. Click here to learn more.

    SWITZERLAND

    Swiss Medical Ordinance has been published. Click here to learn more.

    Germany

    MDR implementing law has been published. Click here to learn more.

    Belgium

    MDR implementing law has been published. Click here to learn more.

    TURKEY

    MDR & IVDR implementing laws have been published. Click here to learn more.

    AUSTRIA

    MDR implementing law has been published. Click here to learn more.

    FRANCE

    MDR implementing requirements have been published and available on MDlaw. The analysis will be published soon.

    FINLAND

    MDR and IVDR implementing law has been published. Click here to learn more.

    LATVIA

    MDR implementing law has been published. Click here to learn more.

    LUXEMBOURG

    MDR implementing law has not yet been published.

    LITHUANIA

    MDR implementing law has been published. Click here to learn more.

    NORWAY

    MDR implementing law has been published. Click here to learn more.

    PORTUGAL

    MDR implementing law has been published. Click here to learn more.

    SLOVAKIA

    MDR & IVDR implementing law has been published. Click here to learn more.

    SWEDEN

    MDR and IVDR implementing law has been published. Click here to learn more.

    LIECHTENSTEIN

    MDR implementing law has been published and is available on MDlaw. The analysis will be published soon.

    GREECE

    MDR implementing law has not yet been published.

    ITALY

    MDR implementing law has been published. Click here to learn more.

    CZECH REPUBLIC

    MDR & IVDR implementing laws have been published and available on MDlaw. The analysis will be published soon.

    SPAIN

    MDR implementing law has been published. Click here to learn more.

    SLOVENIA

    MDR implementing law has not yet been published. Only draft law so far.

    HUNGARY

    MDR and IVDR implementing law has been published. Click here to learn more.

    CROATIA

    MDR & IVDR implementing law has been published. Click here to learn more.

    ICELAND

    MDR & IVDR implementing law has been published. Click here to learn more.

    CYPRUS

    MDR and IVDR implementing requirements have been published and available on MDlaw. The analysis will be published soon.

    GEORGIA

    More info coming soon.

    POLAND

    MDR implementing law has been published & is available on MDlaw. Click here to learn more.

    BULGARIA

    MDR implementing law has not yet been published.

    ESTONIA

    MDR implementing law has been published & is available on MDlaw. Click here to learn more.

    ROMANIA

    MDR implementing law has been published & more information soon on MDlaw.

    MALTA

    MDR implementation law has been published & more information soon on MDlaw.