Before you go on reading, keep in mind nothing is set in stone yet. The proposal still needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.
The Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation (MDR).
Less than a month after the EPSCO meeting took place and a possible transition of the EU-MDR has been published, a next step has been set. One of the highlights from proposal 2023/0005 (COD) are the conditions to be met by the devices and manufacturers to make use of the prolonged transition period. Summarized they look like this:
- The devices must still be compliant with their respective directives (90/385/EEC or 93/42/EEC). Nothing new here compared to the old article 120(3);
- No significant changes are allowed to the design or intended purpose of the device. Nothing new here compared to the old article 120(3);
- The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. The concept of “unacceptable risk to health and safety” as referred below:
- may present an unacceptable risk to health or safety of patients, users or other persons, or to other aspects of the protection of public health, or
- does not comply with the requirements of the MDR
No systematic check of the device’s safety is required. Normal surveillance by the Notified Body is sufficient. Where a competent authority finds that a device presents an unacceptable risk, the transition period ceases to apply to that device;
- No later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the MDR requirements. No specific attestation, i.e., no self-declaration nor verification of the appropriateness of the QMS by a Notified Body, is required at this stage. However, by submitting an application for conformity assessment to a Notified Body (see next condition), the manufacturer implicitly confirms that its QMS is in compliance with the MDR;
- No later than 26 May 2024, the manufacturer, or its authorized representative has lodged a formal application in accordance with Annex VII, Section 4.3, of the MDR for conformity assessment in respect of a ‘legacy device’ covered by a Directive’s certificate or declaration of conformity, or in respect of a device intended to substitute that device under the MDR, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Annex VII, Section 4.3, of this Regulation.
Certain MDR-rules for legacy devices which were already applicable will still be applicable during this transition period and are as follow:
- Post-market surveillance
- Market surveillance
- Vigilance
- Registration of economic operators and devices
Meaning that the devices must have a PSUR in an appropriate frequency, must be registered in EUDAMED in case of vigilance, and manufacturers must register themselves in EUDAMED before the entire QMS is MDR compliant.
The deadlines for the new transition periods are still as follows:
Lastly, as already published the selloff date has been removed from MDR 2017/745 as well as IVDR 2017/746.
From now on, we must wait until the proposal is accepted by the European Parliament and the Council. During this time keep the pace up and work on your transition to MDR. This extension does not mean that the pressure is fully off. The no significant change clause still means that progress cannot get to market as you still must go to MDR right away.
However, it is good to see that more information has been published rather quickly and that steps are being taken toward a situation where device shortages might be prevented.
If you need resources to meet the deadlines or help with transition strategies, schedule a call with a Qserve expert – we're here to help.