Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complemented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.
IVD companies are in risk of being stuck in a traffic jam
The lack of re-designated Notified Bodies puts IVD’s in risk of waiting a long time for re-certification.
One of the forthcoming changes is already making a stir in the industry. The IVDR will significantly change the way IVD’ organizations bear the CE mark, and it will include a completely new risk-based classification system. That means that 80% of all IVD companies will need to be certified by a Notified Body to be compliant with IVDR, whereas under the former IVD Directive, it was only 20%.
The new regulatory changes – the IVDR – will have an impact on In-Vitro diagnostic companies. Unlike the EU MDR, the transition period for EU IVDR is 5 years, so companies will have by May 2022 to be compliant with the new regulatory standard.
The issue of Notified Bodies being under-resourced is known among the industry. A recent survey reports that 50% of the respondents said that their certificate renewal was delayed by their Notified Body while 32% stated that their Notified Body missed or seriously postponed a scheduled audit or product assessment.
Many Notified Bodies failed the re-designation
According to the European Association for Medical Devices of Notified Bodies, there are several reasons for the delays and inability of Notified Bodies to conduct their audits in a timely manner.
The two most significant reasons are the new recommendations and requirements put on Notified Bodies, including the introduction of unannounced audits and the fact that a large amount of the current Notified Bodies did not pass the mandatory re-designation audits. With a failed re-designation, these Notified Bodies are no longer accredited for the certification and are unable to support IVD’s.
The lack of resources is well known to the European Commission and the competent authorities and is expected to be a topic in the current discussions in Brussel.
A clinical evaluation circus
Another issue that is currently happening now is the urgency that is being put on re-designated Notified Bodies to push through clinical data standards that go towards the new MDR level as quickly as possible.
Since the new clinical evaluation platform MEDDEV was adopted, Notified Bodies are beginning to suspend or refuse to renew certificates if they find in a surveillance or recertification audit that the clinical evaluation for the device concerned is not fully up to the standards of the new MEDDEV.
That means immediate suspension – not a minor, not a major, but cease placing on the market with immediate effect. Notified Bodies have even taken this to the level of suspending a certificate with multiple devices on it for all devices, just because the clinical evaluation for one of them (which was not even being placed on the market anymore at the time) was not at the level of the new MEDDEV.
It gets worse
Once the certificate has been suspended or needs to be renewed, there is no way to make a Notified Body hurry up and even act quickly to correct manifest mistakes (like suspending a certificate for all products if only one product is affected by the non-conformity) or otherwise even adhere to basic principles of good administration. The lack of legal recourse here is truly disconcerting, given the enormous damage manufacturers suffer as a result.
Contact your Notified Body today
Because the future for recertification looks far worse than first anticipated, it is highly recommended that IVD’s contact their auditing organization and Notified Bodies to better understand where they stand with the process of being accredited and recognized as a viable resource to conduct the auditing services.
In the messy and choppy transitional period towards both EU MDR and IVDR that we have on the horizon - with less Notified Body capacity but more need for it – the wisest choice is to act proactively.