Transitional provisions for medical devices
In Norway, there are transitional provisions for medical devices, following MDR Article 120 and IVDR Article 110. Some adjustments have been made to accommodate national circumstances in the Regulation on Medical Devices.
Extended Transitional Provisions for Medical Devices
New European regulations for medical devices were introduced on May 26, 2021 (MDR) and 2022 (IVDR) with transitional provisions. Figures from the EU Commission and European industry associations indicate that up to 23,000 certificates may need to be recertified by the original transition deadline of May 26, 2024.
The EU Council has therefore adopted extended transitional provisions for medical device certificates, extending until 2028. The purpose of these transitional provisions is to ensure continued access to and supply of medical devices in the European market.
Dependent on Risk
The European Parliament and the Council have now decided to extend the transition rules in MDR Article 120(3), depending on the equipment's risk class, from May 26, 2024, until:
December 31, 2027, for high-risk equipment:
- Class III
- Class IIb implantable
December 31, 2028, for medium and low-risk equipment:
- Class IIb non-implantable
- Class IIa
- Class I that is sterile equipment and equipment with measuring functions
The decision also introduces transitional provisions until May 26, 2026, for individually tailored Class III implantable equipment.
The prerequisites for the transitional provisions are that:
- The equipment still meets the requirements of Directive 90/385/EEC and Directive 93/42/EEC
- The equipment has not significantly changed in design and intended purpose
- The equipment does not pose a health or safety risk
- Manufacturers are required to, by May 26, 2024:
- Follow the quality system rules per MDR
- Initiate the certification process with an application to a notified body
Read more about the details in the Commission's decision (PDF).
The European Parliament and the Council have also decided to remove the deadline, May 27, 2025, in the so-called "sell-off provision" in MDR and IVDR. This means that equipment still in the supply chain and not yet in the hands of the end-user, such as a hospital, can continue to be marketed and used.
These MDR/IVDR changes were published in the EU Official Journal on March 20 and are legally effective from the same day.
Factsheet (PDF) (External link).
Transitional Provisions for Products Without an Intended Medical Purpose
There are specific transitional rules for products without a medical purpose. These are outlined in Regulation (EU) 2022/2346, as amended by Regulation (EU) 2023/1194. Note that the transitional rules in MDR may also apply to products without a medical purpose.
The transitional rules for products without a medical purpose apply to situations where clinical trials are required, the conformity assessment procedure requires involvement from a notified body, and the product is covered by a certificate in accordance with Directive 93/42/EEC.