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Reliant Life Sciences

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Schedule a few minutes to connect with an expert regarding your project’s advisory and/or staffing needs. Don’t worry, we’ll never spam you.

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Reliant Life Sciences

Send a Message

Send us a message to connect with an expert regarding our advisory and staffing capabilities. Don’t worry, we’ll never spam you.

Consultant Opportunities

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Reliant Life Sciences

Connect with a Recruiter

Complete the following form to connect with a Reliant Life Sciences recruiter regarding opportunities that match your skills and interests. Don’t worry, we’ll never spam you.

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Reliant Life Sciences

Sign-up for Job Alerts

Complete the following form and our team will email you opportunities that match your skills and interests. Don’t worry, we’ll never spam you.

Advisory + Staffing Services

Schedule a Consultation
Reliant Life Sciences

Schedule a Consultation

Schedule a few minutes to connect with an expert regarding your project’s advisory and/or staffing needs. Don’t worry, we’ll never spam you.

Send a Message
Reliant Life Sciences

Send a Message

Send us a message to connect with an expert regarding our advisory and staffing capabilities. Don’t worry, we’ll never spam you.

Consultant Opportunities

Connect with a Recruiter
Reliant Life Sciences

Connect with a Recruiter

Complete the following form to connect with a Reliant Life Sciences recruiter regarding opportunities that match your skills and interests. Don’t worry, we’ll never spam you.

Sign-up for Job Alerts
Reliant Life Sciences

Sign-up for Job Alerts

Complete the following form and our team will email you opportunities that match your skills and interests. Don’t worry, we’ll never spam you.

WHEN IS THE DEADLINE TO REGISTER MY PRODUCT(S) INTO EUDAMED?

Are you confused about the inconsistency surrounding the EU MDR requirements related to the provisions that became mandatory on the date of application; May 26th, 2021? Don’t worry, we got the answers!

In partnership with MDR Consultants, here are a few pointers on how to find the registration date for your products.

Let's start with the 'When'

In accordance with the provisions of Article 120 of the EU MDR (2017/745), on May 26th of 2021 all manufacturers of legacy devices shall have had a quality management system and related outputs, as applicable, conformant to the following requirements of the regulation:

  • Post-market surveillance (article 10)
  • Market surveillance
  • Vigilance (Articles 87 to 92)
  • Registration of economic operations (new article 31)
  • Registration of Devices

Two Guidance Documents

However, it fails to mention the requirements related to the UDI which are needed in order for a manufacturer to be able to register their devices into EUDAMED. Because of this inconsistency in the provisions of the regulation, the European Commission released two guidance documents to guide us through this issue. These two guidance documents include MDCG 2019-4 (Timelines for registration of device elements into EUDAMED) and MDCG 2019-5 (Registration of legacy devices in EUDAMED, class 1 footnote).

Key Takeaways

Registration of legacy devices would be due 18 months (about 1 and a half years) from the date of application of the EU MDR (2017/745) IF EUDAMED was fully functional. Class 1 devices that do not have a CE certificate and are self-declared should be registered as EU MDR devices by the date of the application. However, if EUDAMED is NOT fully functional, all registration is due 24 months (about 2 years) after the notification that EUDAMED is fully functional by this being published in the Official Journal of EU.

As of today, EUDAMED is still not fully functional with three modules still in development. The last official timeline provided by the European Commission can be found here.

MDR Training Programs

The deadline to transition to the EU MDR is May 26, 2024. Are you looking for information on how to start the transition or how to best structure your organization?

Reliant Life Sciences has partnered with MDR Consultants and Isabel Osario to offer hands-on training. To learn more and to sign up, please visit their website