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Latest NEWS: MDR National implementation: Latvia +++ Latest DOCUMENT in our Library: Cybersecurity of Artificial Intelligence in the AI Act +++ Manufacturer self-declaration for legacy devices in STORE now +++ WEBINAR on Steps to enter the Australian market for Medical Devices +++ Our memberships give access to our comprehensive Library of documents, immediate regulatory alerts,...
Latest NEWS: MDR National implementation: Latvia +++ Latest DOCUMENT in our Library: Cybersecurity of Artificial Intelligence in the AI Act +++ Manufacturer self-declaration for legacy devices in STORE now +++ WEBINAR on Steps to enter the Australian market for Medical Devices +++ 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!
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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 law has not yet been published.

    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 implementing law has been published & more info soon on MDlaw.

    SWEDEN

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

    LIECHTENSTEIN

    MDR implementing law has not yet been published.

    GREECE

    MDR implementing law has not yet been published.

    ITALY

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

    CZECH REPUBLIC

    MDR implementing law has not yet been published.

    SPAIN

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

    SLOVENIA

    MDR implementing law has not yet been published.

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

    CYPRUS

    MDR implementing law has not yet been published.

    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.