On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices.
Under the current UK legislation, before a manufacturer can place a UKCA-marked medical device on the market in England, Wales and Scotland, they must secure UKCA marking from a UK Approved Body. This applies to all medical devices and IVDs, except those of the lowest risk classification (i.e., Class I medical devices without sterile/measuring functions and general IVDs).
Three (TÜV SÜD, Intertek, and TÜV Rheinland UK) have been added to the list of four previously designated signatories to guide you to the designated UK signatories as below.
| UK Approved Body | Medical Devices | Active Implantable Medical Devices | IVDs |
| BSI | Y | Y | Y |
| DEKRA | Y | N | N |
| Intertek | Y | N | N |
| SGS | Y | N | Y |
| TÜV Rheinland | Y | N | Y |
| TÜV SÜD | Y | N | N |
| UL International | N | N | Y |
Please refer to the link below for details.
Three new UK Approved Bodies to certify medical devices announced by the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare
www.gov.uk
If you have any questions about medical device certification,
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