EU MDR and IVDR Dates Regulatory and Quality Solutions

Publication in the Official Journal of the European Journal on May 5, 2017 means the regulations will enter into force on May 26, 2017, twenty days after publication. We will have a three-year transition period for the MDR and a five-year transition period for the IVDR. Products can be issued a certificate under the MDD with a full five-year expiry for the first two years of the transition period but should comply with all other aspects of the MDR in May, 2020. Since most IVD products are currently on the market as a self-certified they will require certificates by the end of the five-year transition period where most products now require Notified Body involvement.  

Although there are some pending implementing and delegating acts that will help to bring clarity to the requirements in the MDR and IVDR, you should be assessing the impact to your products and developing your implementation plans. It is not too early to start engaging your key stakeholders including your Notified Body, authorized representatives, and clinical support resources to ensure you have the proper resources to support the transition.

Here's a link to the official publication and below is an outline of key dates.

Description

What parts of the MDR?

Article 123 Entry into Force Timeline

Date

Enter into Force

All

20 days after publication in Official Journal of the European Union

May 26, 2017

Date of Application

All

Three years after entry into force

May 26, 2020

Exceptions (by way of derogation) for NBs and Competent Authorities

Chapter IV Notified Bodies

- Articles 35-50

 

6 months after entry into force until application of the regulations – applies only to NBs who apply for designation

Nov 2017 to May 2020

Exceptions (by way of derogation) for NBs and Competent Authorities

Articles 101 Competent Authorities and 103 Medical Device Coordination Group (MDCG)

6 months after entry into force

Nov 2017

Exceptions (by way of derogation) for NBs and Competent Authorities

Article 102 Cooperation (of Competent Authorities)

12 months after entry into force

May 2018

Eudamed Database

Article 34

Three years after entry OR 6 months after fully functional database notice is provided; until ready follow MDD

May 2020 or

Notice that Eudamed fully functional plus 6 months

UDI – Implantable and Class III Devices

Article 27(4)

Implantable and Class III Devices:

Four years after date of entry into force

May 2021

UDI- Class IIa and IIb Devices

Article 27 (4)

Class IIa and IIb Devices:

Six years after date of entry into force

May 2023

UDI – Class I Devices

Article 27(4)

Class I: Eight years after date of entry into force

May 2025

UDI – reusable devices on the device itself

Article 27(4)

Based on device class

Implants/Class III: May 2023

Class IIa, IIb: May 2025

Class I: May 2027

Coordinated assessment procedure for clinical investigation

Article 78

Single application for a study to be conducted in more than one member state.

Ten years after date of entry into force

May 2027

Transitional Provision: Until designated GS1, HIBCC and ICCBBA are designated issuing entities

Article 120 (12) References Article 27 (2) UDI assignment entities

Two years after date of entry into force

May 2019

Certificates issued under Directives

Article 120 Transitional Provisions

Remain valid through the period on the certificate (except Annex IV EC Verification) but not more than four years after date of application

Issued prior to May 2020 good through certificate expiry up to May 2024

 

Must follow rest of MDR after May 2020

 

Download the slides from our on-demand EU MDR webinar.

 

Download the Slides

 

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