Seminars and Events
The European Parliament has approved a further extension of the MDR transition period
On 6 January 2023 (European time), the European Commission published Proposal 2023/0005(COD) on the transition period provisions amending Regulations (EU)2017/745 and (EU)2017/746. On February 16, 2023, the European Parliament voted on the transition proposal put forward by the European Commission, and it was formally adopted by 537 votes. The final amendment will be published in the Official Journal of the EU (OJ)
On 6 January 2023, the European Commission accepted a proposal to further extend the MDR transition period. On 16 February 2023, the European Parliament voted on the transition proposal put forward by the European Commission. In the end, the proposal was formally approved by 537 votes.
Here's an overview of the most important changes:
| Medical device category | Transition period extension time point |
| Class III implantable custom devices | 05/26/2026 |
| The remaining Class III devices, Class IIb implantable devices | 12/31/2027 |
| Remaining Class IIb devices, Class IIa devices, Class Is devices, and Class Im devices | 12/31/2028 |
| The MDR must include the remaining Class I equipment of the specified institution (e.g. class Ir equipment) | 12/31/2028 |
| Other category of products | 05/26/2021（As before） |
The transition period affects the launch and commissioning, but does not affect sales. Because the sales regulations were completely eliminated.
Stop-sale rule
This means that sales are no longer limited by time. The regulation aims to ensure that "safe and important medical devices already on the market continue to be available to the health care system and the patients who depend on them."
demand
Manufacturers need to meet the following requirements in order for their devices to meet the MDR extension requirements:
1. The device does not pose an unacceptable risk to the health or safety of the patient;
2. There is no significant change in the design and intended use of the device;
3. The manufacturer has established a quality management system QMS in accordance with MDR requirements before May 26, 2024 (MDR Article 10(9));
4. The manufacturer meets the legacy device requirements set out in MDD and MDR;
5. No later than 26 May 2024, the manufacturer or its AR has applied to the notified Body for a conformity assessment under the MDR;
6. No later than September 26, 2024, the manufacturer and the notified body shall sign a written agreement.