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Major milestone for the IVDR implementation in Europe

Thanks to the upcoming changes in European IVD (in-vitro diagnostic) regulations, it has been a challenging time for notified bodies (NBs) and for the in vitro diagnostics industry to prepare for the transition. The changes, from the In-Vitro Diagnostic Devices Directive (98/79/EC) (IVDD) to the In Vitro Diagnostics Regulations (EU) 2017/746 (IVDR), will be effective as of 26th May 2022.

Currently, 80% of IVDs can be marketed through a relatively simple self-certification process. However, under IVDR they’ll be expected to have their tests cleared by authorities for clinical use, including current products on the market. This shift is putting a large workload on NBs, who are also preparing for the transition from the Medical Devices Directive (93/42/EEC) (MDD) to the Medical Devices Regulation (EU) 2017/745 (MDR), due to start in May 2020. Indeed, it was only in January 2019 that BSI UK became the first NB to be designated against MDR.

An interruption of goods provision due to longer regulatory pathways submissions and approvals could lead to an interruption of product supply to hospitals and patient care could also be impacted.

It is clear there is currently a deficit in the NBs for IVDs, and it is still debated how many NBs will proceed to apply and be approved as NB under the IVDR. Of the current major NBs, two of them – Lloyd’s Register Quality Assurance (LRQA) and UL UK – have already decided not to pursue designation under the IVDR (and MDR for UL), withdrawing services. The industry had valid growing concerns with the lack of NBs available, and these announcements this summer came as a surprise to many of their current clients, who were given only 90 days’ notice.

Understandably, the transfer to an alternative service provider has become business critical for the IVD companies, to the point that, in the UK, Medicines and Healthcare Products Regulatory Agency (MHRA) was called upon to assist the clients. An interruption of goods provision due to longer regulatory pathways submissions and approvals could lead to an interruption of product supply to hospitals and patient care could also be impacted. It is believed that the number of NBs seeking designation is now between 10 and 20.

As such, it was a huge milestone for the NB and the IVD industry when on 10th October 2019 Dekra Germany was officially listed in the NANDO database as the first NB designated by the European Commission under the IVDR.

2020 is certainly set to be another challenging year for the IVD industry, in anticipation of the changes to the IVDR, and this milestone should provide some reassurance that the NBs are starting to get through the process.

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