MDR Compliance Timelines
In this short blog we explain that MDR for Class I Medical Devices (Self-certified) is mandatory from 26 May 2021.
In February 2023, the EU Commission extended the Notified Body (NB) certificates issued under the Medical Device Directions (MDD).
The extension is until the end of 2027 (for higher-risk devices such as class III and Class IIb implantable) and until the end of 2028 (for the mid and smaller-risk devices which are other class IIb, class IIa, class Im (with measuring function), class Is (sterile) and class Ir (reusable surgical instruments)), See the EU Extension.
Manufacturers of these medical devices must meet specific criteria such as MDR readiness and an MDR application at a notified body by 26 May 2024.
This extension is intended to give manufacturers more time to achieve compliance with MDR and to “buy” some time for Notified Bodies to process the applications that had amassed towards the end of the grace period.
However, the lowest risk Class I self-certified devices (which are not class Im, Is or Ir, (or up-classified under MDR) are not included in this extension, nor were they included in the original extension (grace period) described under Article 120 of MDR.
The Article 120 Transitional provisions refer exclusively to devices that require Notified Bodies for their conformity assessment procedure.
MDR Article 120 – Transitional Provisions
By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 (Article 120.2) of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.
Therefore, all MDR for Class I Medical Devices is mandatory from 26 May 2021.
Don’t hesitate to contact us if you need any assistance with Class I MDD-MDR transition or any other MDR tasks MDR Compliance.