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EU IVDR

The EU IVDR date was application was 26 May 2022, with a number of the key dates now amended to provide more time for compliance in line with the risk class of the device.

The new dates for implementation will be:

  • 26 May 2024 for certain requirements for devices manufactured in-house (2028 to demonstrate unavailability of an equivalent device)
  • 26 May 2025 for class D devices
  • 26 May 2026 for class C devices
  • 26 May 2027 for class B devices, and class A devices placed on the market sterile
  • Products placed on the market pursuant to transitional periods under IVDD certificates have also been extended by 1 year to 26 May 2025.

Class A (non-sterile) devices still require compliance by 26 May 2022 when the legislation comes into force.

You will need to ensure you meet a number of obligations even if you are taking advantage of the amended transition periods, such as ensuring you meet the IVDR post-market surveillance requirements, had a valid certification or declaration of conformity prior to 26 May, and will not be making any significant changes. We strongly encourage you to continue to move forward with contracting a Notified Body if you haven’t already.

The MDCG have published a number of guidance documents which can provide help in understanding how to comply with the Regulations.

 

UKCA regulations

Work continues within MHRA in developing a new regulatory structure for IVDs within the UK. The planned focus groups are yet to begin, and will hopefully discuss the methods and finer detail of these regulations. We hope these focus groups will give an idea of what we can expect in the requirements.

BIVDA will be involved in these focus groups and our aim is to continue to provide feedback on all areas relevant to the IVD industry.

The official response to the consultation was expected in March 2022, but due to the Government entering the pre-election phase because of local elections, this was delayed. To date, this has not yet been published.

 

Member support

We are aiming to drive key, necessary changes in the regulatory landscape for IVDs and provide support as and when needed to the membership. BIVDA’s UK Responsible Person directory is now live on the BIVDA website, allowing UKRPs to advertise their services to non-UK organisations. Advertising services on this Directory is included within BIVDA membership, or incurs a fee from UKRPs who are not members.

To continue to represent the BIVDA membership to the highest level, it is crucial that we are aware of your opinions. Members are encouraged to continue to feed into consultations to allow BIVDA to provide the voice of the IVD industry. We at BIVDA are here to support with your needs as your Trade Association, so engagement is hugely welcomed to allow us to continue to do so.

Ben Kemp

About Ben Kemp