MDR Europe - What you need to know

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 began to overhaul Europe’s now-defunct Medical Device Directive (MDD). Driving the initiative was a need for a more robust regulatory CE (Conformité Européenne) regulatory system and uniform safety requirements for consumers after a series of high-profile medical device incidents. To address these concerns and restore trust in the EU's medical device oversight, the Medical Device Regulation (MDR 2017/745) was introduced in 2017.

The EU MDR replaces the previous AIMDD (Active Implantable Medical Device Directive) and MDD. The MDR has been fully applicable since May 26, 2021 following the transition period.

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.

Download the Guide & More Resources Below

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

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

We can help you translate your content to stay compliant

Use This Time Wisely: Seven Proactive Steps to take now for EU MDR and IVDR Compliance

Understanding the EU MDR and post-Brexit Regulatory Changes

Working Effectively with Notified Bodies

6 Ways a Centralized Translation Model Can Support Your MDR and IVDR Compliance

Understanding EUDAMED: Its Role in EU Medical Device Regulation

What Is the European Free Trade Association (EFTA) and How Does It Affect MDR + IVDR?

How have the EU MDR and IVDR Changed Clinical Investigations?

Why is Localization Essential for Regulatory Compliance?

How Multilingual Life Sciences Marketing Unlocks Global Markets

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?

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.

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?

EU MDR IFU GUIDE

Download the Guide & More Resources Below

EU MDR TIMELINE

We can help you translate your content to stay compliant

RESOURCES

EU MDR TRANSLATIONS

What You Need to Know

EU MDR & IVDR

Checklist

EU MDR

Regulatory Language Requirements

EU MDR

Under the Microscope

EU MDR

From Preparation to Translation

EU MDR

Instructions for Use Guide

EU MDR

EU Medical Device Regulations & Languages

EU MDR & EU IVDR

The Path to Compliance

Life Sciences

The Pillars of Centralization

Streamline Your Path to EU MDR Compliance

Use This Time Wisely: Seven Proactive Steps to take now for EU MDR and IVDR Compliance

Understanding the EU MDR and post-Brexit Regulatory Changes

Working Effectively with Notified Bodies

6 Ways a Centralized Translation Model Can Support Your MDR and IVDR Compliance

Understanding EUDAMED: Its Role in EU Medical Device Regulation

What Is the European Free Trade Association (EFTA) and How Does It Affect MDR + IVDR?

How have the EU MDR and IVDR Changed Clinical Investigations?

Why is Localization Essential for Regulatory Compliance?

How Multilingual Life Sciences Marketing Unlocks Global Markets

FAQS

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

When will EUDAMED go live?

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

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

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

What are the documentation translation requirements for EU MDR?

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

GET IN TOUCH