Are you ready for the EU MDR?

Deadlines for the EU Medical Device Regulation directive are approaching. Are you IFUs compliant with he new requirements?

2021-2028

May 26, 2021

All devices, except those covered by the extended transition period, must comply with the MDR (e.g. class I, new devices, devices with a significant change)

May 26, 2024

End of the transition period for legacy devices that do not meet the conditions for the application of the new transition periods

May 26, 2024

May 26, 2024

Deadline to lodge an application for MDR conformity assessment and have an MDR QMS in place

May 26, 2024

Mid 2024

Currently, the use of EUDAMED is not required, but some modules are available and can be used voluntarily. However, mandatory use will begin 6 months after the entire EUDAMED system has been declared fully functional following an independent audit, and the publication of a Commission notice in the Official Journal of the European Union. 

Mid 2024

May 26, 2026

End of derogation for class III custom-made implantable devices

Sept 26, 2026

Deadline to sign a written agreement with an NB and transfer appropriate surveillance to an MDR NB (when applicable)

Dec 31, 2027

End of the transition period for class III and class IIb implantable devices (if not excepted, e.g. sutures)

Dec 31, 2027

Dec 31, 2028 1st

End of the transition period for other class IIb, IIa, class I sterile/measuring devices, and devices requiring notified body involvement for the first time under MDR

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RESOURCES

EU MDR - Under the Microscope - Argos Multilingual
EU MDR TRANSLATIONS

What You Need to Know

The new European Union regulations on medical devices (MDR) will require close partnership with localization suppliers to ensure conformance in your translations.

MDR - IVDR Checklist - Argos Multilingual
EU MDR & IVDR

Checklist

With all the things your company is doing to get ready for MDR and IVDR, it’s easy for translation-related items to fall through the cracks. Give yourself additional peace of mind by making sure you’ve checked every box!

Regulatory Language Requirements for MDR
EU MDR

Regulatory Language Requirements

European markets require medical device manufacturers to translate and localize product information to meet regulatory language requirements and the demands of individual Member States.

EU MDR - Under the Microscope - Argos Multilingual
EU MDR

Under the Microscope

The new European Union regulations on medical devices (MDR) will require close partnership with localization suppliers to ensure conformance in your translations.

EU MDR - From Preparation to Translation - Argos Multilingual
EU MDR

From Preparation to Translation

Partnering with the right language service provider is critical to get things right with your languages. Under the requirement of the EU MDR, translations must be accurate, consistent, and technically correct. 

EU MDR Instructions for Use Guide - Argos Multilingual
EU MDR

Instructions for Use Guide

The European Union’s Medical Device Regulation will affect your medical products and their Instructions for Use (IFUs). Ensure you have all the information necessary to conduct a current-state analysis

17908330 EU Medical Device Regulation & Languages - Argos Multilingual
EU MDR

EU Medical Device Regulations & Languages

Q&A on the regulation, continued compliance and the impacts on content translations. Find the answers for questions we frequently asked by life sciences companies.

MDR & IVDR - The Path to Compliance
EU MDR & EU IVDR

The Path to Compliance

LSPs are seeing an increase in the amount of requests for information on the steps required to obtain a CE marking for medical devices intended for sale in the EU. While there are variables involved depending on the specific type of device, there are similar core steps to be taken toward a CE marking.

EU MDR Instructions for Use Guide - Argos Multilingual
Life Sciences

The Pillars of Centralization

In a world of increasing compliance demands, a centralized content strategy is vital for accelerating time to market while increasing quality and cost savings. Learn core concepts and practical steps to create greater content accuracy, consistency and compliance in medical device documentation. 

FAQS

What is the purpose of the Medical Device Regulation (MDR)?

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

As a result, the European Commission presented two legislative proposals in September 2012. Following 5 years of consultation and negotiation, a new set of regulations was established to govern manufacturers, distributors, notified bodies, importers, suppliers, and member states in regard to medical devices.

 

When will EUDAMED go live?

Currently, the use of EUDAMED is not required, but some modules are available and can be used voluntarily. However, mandatory use will begin 6 months after the entire EUDAMED system has been declared fully functional following an independent audit, and the publication of a Commission notice in the Official Journal of the European Union (OJEU).

It is currently anticipated EUDAMED will be published in the OJEU in mid-2024, with a transition period to follow.

What are the important changes in the Medical Device Regulation (EU MDR)?

- The introduction and launch of EUDAMED, a comprehensive database for all medical devices sold within European markets.

- Inclusion of non-medical and cosmetic devices previously not considered as medical devices.

- Both medical purpose devices and active implantable medical devices (AIMD) are now encompassed under MDR.

- Devices will now feature Unique Device Identifiers (UDIs) on their labels to enhance traceability.

 

Do I need to recertify my CE-certified medical device?

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.

How does the EU MDR differentiate between devices used by patients and professionals?

The EU MDR does not distinguish between lay use and professional use in terms of requirements for device design, manufacturing, risk, or safety.

What are the documentation translation requirements for EU MDR?

Depending on target markets and distribution strategies, some products may require translation into as many as 24 languages. In addition, more than 20 information pieces may be required for each product label or IFU, depending on the device classification.

Will we need to work with a Certified Language Service Provider?

Collaborating with a certified translation and localization provider, especially one with expertise in medical language services and ISO registration, is crucial to navigate the complex international regulatory landscape. Choosing the right translation provider ensures accuracy, consistency, and technical correctness of translations.

GET IN TOUCH

To learn how Argos Multilingual can guide you and your business through the EU IVDR directive and its requirements, please get in touch with us by filling in the form.