On May 25th and June 13th, 2022, the Medical Device Coordination Group (MDCG) released two new guidance documents. A Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 (MDCG 2022-10) and a position paper, which is a notice to manufacturers to ensure timely compliance with MDR requirements (MDCG 2022-11).
MDCG 2022-10 – Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746
This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on
clinical trials for medicinal products for human use (CTR) and the IVDR. It was developed by clinical trials experts from Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts from the IVD sub-group of the MDCG.
The document addresses some key questions such as:
- Do all IVDs used in a clinical trial require CE marking at the time of the clinical trial?
- When does an assay used on human samples qualify as an IVD in a clinical trial? In which situations may a non-CE marked IVD (or an IVD that is CE marked for another intended purpose) be used in a clinical trial for a medical purpose according to the IVDR?
- Is there a common EU procedure for combined trials?
- What are the respective responsibilities of the clinical trial sponsor and IVD manufacturer including in the case of co-development and use in a combined trial?
MDCG 2022-11 – MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements
When the MDR went into effect on 26 May 2021, manufacturers were given time to transition to the new regulation, with the transition period ending on 26 May 2024. This transition period intends to give further time to the system to prepare and to get ready, for example for manufacturers to prepare their quality management systems (QMS) and technical documentation before applying to a notified body. This step should not be perceived as a “grace period” to postpone the entering into application of the new rules.
Unfortunately, data collected by notified bodies, and presented to competent authorities in December 2021, shows that nearly 37% of manufacturers’ applications have been refused based on incomplete applications, underlining an overall lack of manufacturers’ preparedness. In April 2022, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete.
Therefore, in this position paper the MDCG urges manufacturers to start preparing now to ensure that devices can continue to be placed on the market and to avoid shortages. Manufacturers should adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period. Devices not certified by 26 May 2024 will no longer have access to the EU market, except in rare circumstances.
What does this mean to you?
MDCG 2022-10 is an interesting source when your IVD will be used in the context of a clinical trial. It addresses some of the key questions regarding the device’s regulatory status and the expectations towards the clinical trial sponsor.
MDCG 2022-11 is a reminder to all manufacturers to not delay their transition to the MDR. It is also a clear that now too many files submitted are still lacking. You should always aim at doing it right the first time and plan well ahead to avoid market disruptions.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.