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Latest NEWS: MDCG Guidance on Questions and Answers on vigilance terms and concepts as outlined in MDR +++ Notified Body: BSI Medical Device Regulation mapping guide +++ Latest DOCUMENT in our Library: CEN and CENELEC Work Programme 2023 +++ IVDR/MDR PRRC Job Description/Designation Letter in STORE now +++ WEBINAR on differences between EU IVDR and CH IvDO+++ Our memberships give access to our comprehensive Library of documents, News section, regulatory alerts,...
Latest NEWS: MDCG Guidance on Questions and Answers on vigilance terms and concepts as outlined in MDR +++ Notified Body: BSI Medical Device Regulation mapping guide +++ Latest DOCUMENT in our Library: CEN and CENELEC Work Programme 2023 +++ IVDR/MDR PRRC Job Description/Designation Letter in STORE now +++ WEBINAR on differences between EU IVDR and CH IvDO+++ Our memberships give access to our comprehensive Library of documents, News section, 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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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 implementing law has been published & more info soon on MDlaw.

    AUSTRIA

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

    FRANCE

    MDR implementing law has not yet been published.

    SPAIN

    MDR implementation law has been published & more information soon on MDlaw. Click here to learn more.

    FINLAND

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

    LATVIA

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

    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.

    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 is in the pipeline. 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.