Requirements to register
Medical Devices have particular requirements in the UK to meet regulatory requirements. All manufacturers must be registered on the MHRA database. This applies both to manfucaturers based in the UK and manufacturers based outside the UK.
All medical devices, including in-vitro diagnostic devices, must be individually registered on the MHRA database before they can legally be sold in the UK.
If you're based outside the UK
For manufacturers based outside the UK they must employ a UK based responsible person. The details of the responsible person must be registered on the MHRA database.
There must be a regulatory agreement in place between the UK responsible person and the manufacturer if the manufacturer is based outside the UK. This requires approval by the MHRA.
For product registration other than class 1 non sterile, they must additionally be supported by a Current Notified Body "CE" or UK Approved Body "UKCA" certificate. In the case of Class 1 non-sterile devices, the requirement is for a copy of the relevant "UKCA" or "CE" Deceleration of Conformity and not a "CE" or "UKCA" certificate.
N.B. Devices with a measuring function are also required to have a Current Notified Body "CE" or UK Approved Body "UKCA" Certificate.
Non-UK based medical device manufacturers must meet the UK regulations (2002-618 as amended), this may be done with compliance to 93/42. EC (EU Medical Device Directive with an extension under article 120) or 2017-745 (EU Medical Device Regulation MDR) or the IVD equivalents 98/79EC, with an extension under article 110, or EU 2017-726 (EU IVDR Regulation).
How we can help you
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Once we have all of the required documentation we are able to register your company and products within 2 working days. The MHRA will notify us as soon as they have reviewed the submittal. This is normally within one working week but can take longer.
Registration onto the MHRA MORE System would also be required to record any vigilance issues.
We charge an annual fee for general maintenance and identify where costs would increase. Note that any costs applied by the MHRA would be charged in addition, this covers additional devices registrations, initial registration, and updates to documents (e.g. new regulatory agreement, change from compliance to 93/42 to compliance to 2017-745).
We are also able to obtain Certificates of Free Sale (CFS).