ARE YOU READY FOR
THE EU MDR?

The deadline to the EU Medical Device Regulation directive is approaching.
Are your IFUs compliant with the new requirements?

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EU MDR Timeline

There are several important dates to remember during
the implementation of the new regulation.

MAY 26, 2017

EU MDR Published and Entered into Force.

NOV 26, 2017

Notified Bodies may apply for designation according to the EU MDR.

MAY 26, 2021

MDR date of Application. EC Certificates of Conformity issued before May 26th, 2017 will expire.

MAY 26, 2022

EUDAMED will go live.

MAY 26, 2024

Notified Body certificates issued under AIMDD and MDD designation become void.

MAY 26, 2025

Devices certified under the AIMDD and MDD can no longer be sold or distributed.

EU MDR IFU GUIDE

The European Union’s Medical Device Regulation will affect your medical products and their Instructions for Use (IFUs).

In 2008, an effort was started to overhaul the medical device directive. This was due to several high-profile medical device scandals and increasing public concern to strengthen the existing CE regulatory system. In 2017, the MDR directive (2017/745) was published to address these issues and bolster confidence in the EU medical device regulation system.

The EU MDR will replace the current AIMDD (Active Implantable Medical Device Directive) and MDD (Medical Device Directive) and by May 26, 2020 all medical device manufacturers will need to be compliant.

Ensure you have all the information necessary to conduct a current-state analysis and pinpoint the areas that need to be addressed according to new regulatory requirements in the EU MDR directive.

Key Takeaways:

Learn how IFUs and patient manuals will be affected by the EU MDR.
Understand the implications of MDR on CE marked products.
Identify the language gaps for distributing products in the European Union.

Register to download our FREE EU MDR IFU Guide and to get exclusive access to all our other MDR resources.

Sign up for a FREE copy of the
EU MDR IFU Guide and more.

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EU MDR resources available on this website.

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EU MDR
RESOURCES

To better understand the requirements of the
European Union's Medical Device Regulation and the impacts on language, download and read our other resources on the EU MDR.

Register once, and get access to all our resources.

Get in touch with us for more information.

EU Medical Device Regulations & Translations

EU Medical Device Regulation Checklist

EU Medical Device Regulation and Languages Q&A

Regulatory Language Requirements for Medical Devices in the European Union

The 2017 EU Medical Device Regulations Under The Microscope

Get in
touch

For more information on how Argos Multilingual can support you and your business with the
EU MDR directive and its requirements, please reach out to us by filling in this form.

mdr@argosmultilingual.com +1 (303) 516-0857 (US) +353 1 503 0978 (EU)

EU MDR
Frequently Asked Questions

Browse our knowledge base

The existing regulatory framework has been in place for nearly 30 years. It has been amended on an ad hoc basis in that time, but pressure to modernize it in order to better address risk management and guarantee the continued safety of medical devices sold in the European Union has been growing.

As a result, the European Commission presented two legislative proposals in September 2012, which were followed by five years of consultation and negotiation that concluded with a new set of regulations affecting manufacturers, distributors, notified bodies, importers, suppliers, and member states.

March 26, 2020

One of the key developments is the creation of EUDAMED, a database for all medical devices sold to European markets.
Non-medical and cosmetic devices that were not classified as medical devices will now be added to the list. Also, medical purpose devices and AIMD are both included under MDR.
Unique device identifiers (UDIs) will be placed on device labels to provide traceability.

All existing CE marked products will need to be recertified against MDR to retain the CE mark and continue to sell products in the EU.

The EU MDR does not distinguish between lay use and professional use with regard to requirements for device design, manufacturing, risk, or safety.

Depending on marketing and distribution objectives, some products may require the translation of content in up to 24 languages. In addition, there can be more than 20 information pieces required for each product label or IFU, depending on classification.

Working closely with a translation and localization provider who specializes in medical language services and is ISO registered is an important step in conquering the ever-changing international regulatory process. The choice of translation provider is critical in order to guarantee that translations are accurate, consistent, and technically correct.

Click here for more information about our Medical and Healthcare Translation Services.

ARE YOU READY FOR THE EU MDR?

The deadline to the EU Medical Device Regulation directive is approaching. Are your IFUs compliant with the new requirements?

Sign up for a FREE copy of the EU MDR IFU Guide and more.

ARE YOU READY FOR
THE EU MDR?

The deadline to the EU Medical Device Regulation directive is approaching.
Are your IFUs compliant with the new requirements?

Sign up for a FREE copy of the
EU MDR IFU Guide and more.