Seminare und Veranstaltungen
Das europäische parlament verabschiedete offiziell die verlängerung der mdr-übergangszeit
Am 6. Januar 2023 hat die europäische kommission einen vorschlag zur änderung der verordnung 2017/745 und 2017/746 bekannt gegeben. Am 16. Februar 2023 legte das europäische parlament eine abstimmung über den übergangsvorschlag der europäischen kommission ab und verabschiedete ihn mit 537 stimmen formell. Die endgültige änderung wird dann im offiziellen bulletin der europäischen union (o.j.) veröffentlicht
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.