IVDR – End of the transition period

On 26 May, the In Vitro Diagnostics Regulation (IVDR) finally comes into force. After a five-year transition period, the comprehensive EU Regulation 2017/746 is still a challenge for manufacturers – with the aim of increasing the safety and health protection of patients and users. From the redefinition of risk classes to the designation of responsible persons: With the IVDR, a second concretised EU regulation in the field of medical technology is being implemented after the MDR. A brief overview.

Classification of in vitro diagnostic medical devices (IVD) – how is the classification done?

Risk classification

With the end of the transition period, many class A products will be classified higher. The reason for this is a new system for risk classification, which is intended to create more safety. This is because a notified body must be involved in the conformity assessment procedure for products in risk class A sterile, B, C and D.

One disadvantage of the new system is that, according to TÜV SÜD, the notified bodies are to test around 80 to 90 per cent of all IVDs in future. An increasing approval backlog could be the result.

Good to know

Having a CE-marked product on the market does not mean finality. This is because in vitro diagnostic medical devices approved according to the IVDD must also fulfil the requirements of the IVDR. By 26 May 2022, this proof must also be available.

Person(s) responsible
The naming of at least one qualified, responsible person within the company is now mandatory. This person is responsible for compliance with the regulatory requirements under Article 15 of the IVDR. Finally, the central EUDAMED database will list which person(s) are responsible.
Technical documentation and performance evaluation
It gets even more detailed: In addition to the increased documentation effort for the technical documentation, the IVDR requires additional and longer-term data from manufacturers, for example on scientific validity and clinical performance. Even after the IVD product has been placed on the market, an evaluation must be continued.
Post-Market Surveillance (PMS)
Systematically collecting, evaluating and assessing feedback – this is what the IVDR requires. Because PMS is an essential aspect of the quality management system. For products of risk classes A and B, findings must be documented in a report; results of products of classes C and D must be maintained by manufacturers in a performance report (PSUR).

PSUR: This should be in the report

A periodic safety update report (PSUR) is a performance report updated at least once a year. It provides findings on IVD products in risk classes C and D and should include: PMS results, risk-benefit assessment and data on sales and use of the IVD.

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IVDR – End of the transition period

Risk classification

PSUR: This should be in the report

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