Expected surprise! The IVDR is once again going to be postponed!!

On January 23rd, local time in Brussels, the European Council issued proposal 2024/0021 (COD) regarding the further postponement of the IVDR. It is worth noting that this proposal for extension is an additional delay to the proposal 2021/0323 (COD) issued on October 14, 2021.

According to the IVDR regulations, approximately 80% of IVDs will undergo scrutiny by notified bodies, with the majority being reviewed for the first time. As a result, the number of certificates issued under IVDR is expected to be significantly higher than those issued under Directive 98/79/EC. Due to the complex relationship between the number of devices and the number of certificates covering the devices, it is not possible to provide an exact calculation. However, a reasonable estimate would be around 15,000 certificates or more. Over 1,000 devices fall under the highest risk category (Class D), which requires the issuance of a quality management system certificate and an individual device technical documentation assessment certificate, according to the IVDR.

These numbers contrast starkly with the relatively low number of certificates issued and ongoing applications under IVDR. In fact, the majority of IVDs have not yet transitioned to the IVDR. As of the end of October 2023, manufacturers have submitted 1,378 applications for conformity assessments under IVDR, resulting in the issuance of 677 certificates by notified bodies across all risk categories. As for Class D certificates, only 335 applications have been submitted, leading to the issuance of 117 certificates.

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Expected surprise! The IVDR is once again going to be postponed!!

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