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.
Early January 2023, the Commission adopted a proposal that introduces a longer transition period for medical devices to the requirements as documented in the Medical Devices Regulation (MDR) after discussions on possible measures to mitigate shortages of medical devices after 26 May 2024 in the EPSCO meetings of June 2022 and December 2022 . The most important items in this proposal have been summarized by our colleague Robert Paassen (Big News From the European Commission Regarding the Transitional Provisions for Certain Medical and In Vitro Diagnostic Medical Devices (qservegroup.com)).
If the proposal is accepted, manufacturers are granted more time to transition to the MDR. With a proposed deadline for transition of class III and class IIb implantable devices of 31 December 2027, more than 2.5 years are added for manufacturers to comply. For class IIb, IIa, Is and Im devices of 31 December 2028, the proposed extension is even a year longer. For custom-made devices, the deadline is 31 December 2026. This seems long, but it is important to realize that although the timelines for transition are proposed to be extended, the MDR requirements on safety and performance will not change. Furthermore, it is important to note that the Commission proposal requires that the manufacturer and the Notified Body have signed a written agreement for conformity assessment in a timely manner (before expiration of the MDD certificate or before 26 September 2024 for certificates that expire 26 May 2024). Although Notified Bodies might not directly be ready to start the conformity assessment process, a manufacturer needs to be ready any time for conformity assessment as soon as the agreement is signed.
Many manufacturers struggle showing their devices have sufficient clinical data as required by MDR article 61 on clinical evaluation. Many class III, IIb and IIa devices that are CE-marked under the Medical Device Directive (MDD) do not have clinical study data or literature data available and only limited post market clinical follow-up (PMCF) data have been collected. In those cases, the Notified Body may well reject your claim of sufficient clinical data.
The proposed extension will give you time to collect clinical data in case you do not have sufficient clinical data. However, this is a lengthy process. So don’t take your foot off the gas and use this time wisely!
A relatively cheap and easy way to collect clinical data on your already marketed device is a PMCF survey. With a PMCF survey, you will collect clinical data on the clinical safety and performance of your device as used in individual patients. As is the case in clinical studies, the PMCF survey is deployed based on a plan, with objectives and acceptance criteria. The sample size is statistically justified. After completion of data collection, the data will be analyzed and reported.
If we are granted more time for the transition to the MDR, you even have time to start a clinical study. However, as a study usually has longer timelines than a PMCF survey, it is recommended to carefully plan the study to ensure that the clinical data are available in a timely manner to support your MDR submission.
In case you want strategic and/or practical support or resources, including assessment on sufficient clinical data, doing a clinical study or a PMCF survey or for writing a clinical evaluation, schedule a call with a Qserve expert – we are here to help!