Medical Device Regulations Changes coming with Brexit.
Listen to the entire episode where we go over Brexit and all of the important things happening in the Medical Device industry here.
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Changes with Brexit
The UK will not be transitioning to the EU MDR or IVDR and will be staying with MDD, AIMD, and IVDD. They plan on making changes in the future as necessary for the UK market.
The MHRA will recognize the CE Mark for devices until June 30th, 2023. This applies to products CE marked under the
- MDD, IVDD, AIMDD, and as well as MDR and IVDR.
- Class I and General IVD manufacturers can continue to self declare.
Conformity Assessment Marking (UK CA)
- UK Notified Bodies will become UK approved bodies starting January 1st, 2021
- Device Manufactures can use UK approved bodies for UK CA marking starting on January 1st, 2021
- UK CA marking will be mandatory on July 1st, 2023
MHRA Registration Requirement Dates
- May 1st, 2021
- Class III medical devices & IVD list A devices
- Class II b implantable devices
- September 1st, 2021
- Class II b non-implantable and II a & IVD list b products
- September 1st, 2022
- Class I medical devices and general IVDs
UK Responsible Person
Manufactures without a presence in the UK will need a UK responsible person which can be an individual or company similar to EU authorized representative.