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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.
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