MDlaw – Information platform on European medical device regulations MDlaw – Information platform on European medical device regulations
BECOME A MEMBER
0
Latest NEWS: EP to vote on revised MDR & IVDR on 25 April +++ Latest DOCUMENT in our Library: Content of Investigator Brochure under MDR +++ Manufacturer self-declaration for legacy devices in STORE now +++ WEBINAR on IVDR legacy extension and EUDAMED gradual roll-out +++ Our memberships give access to our comprehensive Library of documents, immediate regulatory alerts,...
Latest NEWS: EP to vote on revised MDR & IVDR on 25 April +++ Latest DOCUMENT in our Library: Content of Investigator Brochure under MDR +++ Manufacturer self-declaration for legacy devices in STORE now +++ WEBINAR on IVDR legacy extension and EUDAMED gradual roll-out +++ 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!

All information. A single platform.

Up-to-date

We are the fastest in processing and communicating news on MDR & IVDR.

Comprehensive

The only platform providing all MDR and IVDR information. Accessible, comprehensive, comprehensible.

Personalised

Choose from a broad range of single-purchase digital products and our membership plans.

Become a member

We offer one-time purchases as well as memberships.

BECOME A MEMBER
Membership

Gain exclusive access to our platform, navigate freely through the library of documents, and receive the latest information on the European medical device regulations.

VISIT OUR STORE
Store

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.

STREAM A WEBINAR
Webinars

Get informed on the new requirements in a more interactive way.

NATIONAL REQUIREMENTS FOR MEDICAL DEVICES (MDR)

Click on the specific country to learn more!

MDlaw, briefly explained.

The latest news and updates.

Our members stay up to date.

Annual

Pro with TRIAL

30€ /month. 3 months free.

Annual membership. One-time payment.

  • Quick and easy access to our library of documents.
  • Access to MDR/IVDR national analysis.
  • Immediate regulatory alerts (directly in your mailbox)
  • A monthly summary of the most important news and automatic alerts on new posts.
  • 100% free if cancelled within the first 3 months
SELECT PRO + FREE TRIAL

Premium

90€ /month

Annual membership. One-time payment.

  • Quick and easy access to our library of documents.
  • Access to MDR/IVDR national analysis.
  • Immediate regulatory alerts (directly in your mailbox).
  • A monthly summary of the most important news and automatic alerts on new posts.
  • [EXCLUSIVE FOR PREMIUM MEMBERS] Access to 5 guidance and analysis documents selected by our experts (List)*
SELECT PREMIUM

Gold

230€ /month

Annual membership. One-time payment.

  • Quick and easy access to our library of documents.
  • Access to MDR/IVDR national analysis.
  • Immediate regulatory alerts (directly in your mailbox)
  • A monthly summary of the most important news and automatic alerts on new posts.
  • [EXCLUSIVE FOR GOLD MEMBERS]. Access to templates, guidance and analysis documents prepared by our experts (List)*
  • [EXCLUSIVE FOR GOLD MEMBERS] One of the following:
    • A recorded training on their preferred MDR & IVDR topic OR
    • Receive advice on a MDR & IVDR related query
SELECT GOLD

* Otherwise available for single purchase from our store.

Monthly

Pro

35€ /month

Annual membership. Monthly payment.

  • Quick and easy access to the Library of documents
  • Monthly summary of the most important news
  • 50% off on a Store document of your choice
  • Cancel anytime after the 12-month minimum subscription period
SELECT PRO

Premium

105€ /month

Annual membership. Monthly payment.

  • Quick and easy access to the Library of documents
  • Monthly summary of the most important news
  • Cancel anytime after the 12-month minimum subscription period
  • Weekly regulatory alerts
  • Access to 5 guidance and analysis documents selected by our experts*
SELECT PREMIUM

Gold

255€ /month

Annual membership. Monthly payment.

  • Quick and easy access to the Library of documents
  • Monthly summary of the most important news
  • Cancel anytime after the 12-month minimum subscription period
  • Weekly regulatory alerts
  • Access to all guidance and analysis documents prepared by our experts*
SELECT GOLD

* Otherwise available for single purchase from our store.

Obelis clients

Existing Obelis clients receive free access to the MDlaw Pro membership. Please submit the form below for us to verify your data.

    * Required fields

    © MDlaw.
    Privacy policy.

    MDlaw.eu
    mdlaw@obelis.net
    +32(0)2 7325954

    Disclaimer: The content on this website does not provide legal advice and is for information purpose only. Obelis accepts no liability for any inaccuracies or omissions in the information in its website and any decisions based on such are under the sole responsibility of the reader.

    Powered by Obelis Group

    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.