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Compliance with regulation

Compliance with standard EN ISO 13485

Almost all our IVD kits have the CE IVD mark indicating compliance with the standard EN ISO 13485. Annual audits confirm that all the matters regarding company management, manufacturing, storage and logistics of the kits are compliant with the standard.

Until 2022, production of IVD is provided according to the existing IVD Directive (98/79/EC) legislation (further referred to as “the old Directive”).

After 2022, the production will be managed according to In Vitro Diagnostic Device Regulation (EU) 2017/746 (abbreviated as „IVDR“, further referred to as “the new Regulation”).  

Until 2022, there is a transition period when both rules are valid simultaneously. Due to the overlapping period, some IVD products notified according to “the old Directive” can be supplied under some conditions until 2025. After this year all “old notifications” become void.

New features of the new Regulation (IVDR)

Whereas under the old Directive all our IVD kits were classified in the class “others”, the new Regulation puts all the kits we manufacture into the class “C”. This new classification means a completely different approach to them.

According to the old Directive, notification of a new product was a quite simple process of announcement. When all necessities were performed, such as validation of the product, completing final report etc., launching of the product was simply announced to the national body and the product started to be sold.

The new Regulation requires a class C process of notification of each product through a notified body. The complexity of the process is hardly comparable to what was required by the old Directive. Brand new documents required for each IVD product are required: risk management plan, performance assessment, clinical evaluation, post-market surveillance. The whole extent of product documentation is increased considerably.

Generally, new Regulation requirements are much broader and much deeper. Where one person dealing with the process of notification of a new product was sufficient, now a team is needed to cover all parts of the notification process. It is clear that expenditures for personnel costs and services of a notified body will dramatically increase the manufacturing cost of the IVD production.

Congestion on part of notified bodies

There is another issue connected to transformation from the old Directive to the new Regulation.

The IVDR 2017/746 appeared simultaneously with Medical Device Regulation (EU) 2017/745 (MDR). The MDR orders similarly tough rules for manufacturers of medical devices (it covers every consumable used in medical health care). The requirements for implementing the MDR are analogically similar as those for the IVDR, but all the terms of implementing are 2 years earlier.

It results in the fact that a very limited number of notified bodies in EU is completely and urgently engaged in the MDR notification for their customers – manufacturers of medical devices. Their obligatory term of notification is in May 2020. Therefore, requirements of IVD manufacturers are often sidetracked by the notified bodies.