Postponement of the entry into force of the IVDR Regulation

On 14 October, the European Commission proposed a postponement of the entry into force of the IVDR Regulation, which was due to enter into force on 26 May 2022.

This request follows a report issued by MedTech Europe which surveyed IVD product manufacturers, showing that almost 25% of products would be discontinued; and furthermore, this discontinuation would be mainly in specific procedures which in some cases could lead to a lack of sufficient devices to meet the demand of citizens.

What are the deadlines for adaptation to the IVDR Regulation?

The deadlines for entry into force are amended as follows:

In the case of an EC certificate issued by a Notified Body based on Directive 98/79/EC, provided that it was issued before 25 May 2017, it shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI of Directive 98/79/EC which shall expire at the latest on 27 May 2025. Those issued after May 2017 will be valid until 27 May 2025.

Automark products that are upgraded to Class A-sterile, B, C or D may be placed on the market or put into service until the following dates:

– 26 May 2025 for Class D devices;

– 26 May 2026 for Class C devices;

– 26 May 2027 for Class B devices;

– 26 May 2027 for Class A products marketed under sterile conditions;

 

Provided they have a Declaration of Conformity issued before 24 May 2022. For practical purposes, this means having a manufacturing licence granted prior to this date, and a Technical File approved and in force in accordance with the requirements of Directive 98/79.

 

In the case of Class A products, there is no change in the deadlines, and the adaptation to the regulation must be carried out before 24 May 2022.

 

The extension request document, provides that they may be placed on the market or put into service until the dates laid down provided that they continue to comply with Directive 98/79/EC as from the date of application of this Regulation and provided that there are no significant changes to the design and intended purpose.

At Episkey Medical Consulting we can help you with the adaptation of your in vitro medical device.

 



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