Timetable for the compliance with the MDR/IVDR and Notified Bodies: where we stand
In July 2023 the European Commission has published the first results of the survey carried out by Gesundheit Österreich GmbH (the Austrian National Institute for public health), Areté and Civic Consulting with the aim of monitoring and examining the availability of medical devices on the EU market in the frame of the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) from the point of view of the main stakeholders.
The study, that started in December 2022 and will end in 2025, compares the outcomes of the investigation carried out at the beginning of April 2023 based on the data from 39 notified bodies designated based on MDR and/or IVDR up to 31 March 2023 to the data collected by the European Commission between February 2021 and October 2022.
The resulting picture is not reassuring.
The situation of the Medical Devices
As far as MDs are concerned, it results that an average of 2 to 3 months elapse only between the submission of the application by the manufacturer and the signing of a written agreement with a NB.
Then, the time to obtain a certificate is still very long and varies depending on whether the certificate is finalised only to obtain a QMS (6 to 12 months) or a QMS and product (13 to 18 months).
Another aspect that was highlighted is that the rate of MDR applications that are still incomplete has increased. And it’s such incompleteness in the documentation submitted with the application that is at the top of the reasons for its rejection along with the erroneous area of interest in the designation of the notified body for the concerned product and the wrong classification of the product/device.
The situation of the In Vitro Diagnostics
A similar situation is described for the IVDs: also in this case most of the applications are incomplete for very different reasons and the time required to obtain a IVDR certificate is in most cases 13 to 18 months.
For this category of products, the survey has highlighted also the few applications received and the little number of certificates released compared to October 2022.
This is an issue to be stressed as, even more than for manufacturers of MDs classified in class I by the Directive, IVDs manufacturers that have to relate for the first time with a NB to demonstrate the conformity of their products in the stricter framework imposed by the IVDR will be many.
The reason for this is that the new rules of classification introduced by the IVDR will bring many devices in higher risk classes.
Notified bodies worried about medical devices
The medical device notified body association TEAM-NB has promptly released a “position paper” on the new timetable of the MDR transitory period and the capacity of notified bodies.
In this document, NBs express their strong concern after having seen MDR certification applications reduced as early as the end of 2022, namely when the first draft of the regulation that extended the transition period started t be circulated.
Although the first deadline of 26 May 2024 established by Regulation (EU) 2023/607 is near at hand, NBs did not see any new increase in the number of applications by manufacturer, as expected.
Technical documentation unsuitable
Moreover, regarding the applications received so far, the NBs complain for many devices the submission of unsuitable technical documentation and are critical about the staggered approach adopted by many manufacturers to certify their product portfolio gradually.
Besides, as already confirmed by the data from the survey published by the Commission, many applications are considered incomplete, and need further information before the actual evaluation can be started with a consequential increase in the time required to release the relevant certificates.
The transitory period
NBs also stress that, although the extension of the transitory period aims at staggered deadlines to prevent bottlenecks and ensure an easy and manageable transition process, it has established fixed and strict deadlines that do not guarantee a positive outcome.
In fact, Regulation (EU) 2023/607 provides for specific requirements to be able to benefit for the time extension with the prospect of ensuring that manufacturers work in view of the MDR since the start.
NBs have therefore urged manufacturers to submit a complete MDR application as soon as possible and not to wait the last minute, because new workload peaks could occur.
From their side, the NBs say they are fully committed to play their part in the transition process to the new regulations adopting essential measures to enhance their resources and capacity in order to meet the growing demand and requirements imposed by the MDR, investing to widen their workforce and to train new and current staff and improving in-house processes, competence and infrastructure to be in line with the new legal framework.
On the other side, they also point out the need to reduce the time for the NB designation (in some cases exceeding 800 days), to prevent any limitation to the global capacity to carry out conformity and certification evaluations.
Little time left to comply with the regulations
In light of all this, it is clear that the time available to comply with the new regulations is actually very little and it is important to make sure that this process starts as soon as possible.
In parallel, it is essential that MD and IVD manufacturers commit to submit a complete, exhaustive and suitable documentation to already overburdened NBs, having now very long evaluation waiting lists and timetables, in order to prevent the withdrawal of their products from the market.
From this perspective, Di Renzo Regulatory Affairs is able to support manufacturers in various apsects of the process to comply with the new legal framework.
Written by Simone Pippa on 12/10/2023
