Everything You Need to Know About MHRA Registration

According to the rule of the MHRA of the Medicines and Healthcare products Regulating Agency (MHRA) of the UK, for manufacturers of medical devices in the UK, having an MHRA registration has been mandatory.

Nonetheless, the medical device manufacturers who are based in the UK are eligible for getting registered with the MHRA. So, if you are a foreign manufacturer but don’t have any local office in the UK, then the only option for you is to appoint a UK-based authorized representative who will function on behalf of your company and being a representative of it, the professional will be responsible to make all communications with its regulating authority.

It is equally important to state that starting from January 2021, there has been a requirement for new registration.

As per the regulations applicable, only the medical device manufacturers in the UK, as well as their authorized representatives, can get registered with the MHRA, whereas the distributors or suppliers are not allowed the authority to get such recitation.

Before introducing the medical equipment and tools on the UK market, the manufacturer will have to submit the required documents explaining that the medical device proposed to be launched in the market, need to meet the requirements as formulated by the Medical Devices Regulations. Noteworthy that the scope of the prevailing policy encompasses medical devices compliant with the EU-wide regulations as stated below:

The Medical Device Directive/ MDD,The Active Implantable Medical Devices Directive (AIMDD),The In-Vitro Diagnostic Medical Devices Directive (IVDD),The Medical Devices Regulation 2017/745 (MDR),The In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR)

As stated earlier, a medical device manufacturer from overseas will require to appoint a UK responsible person as an authorized representative before launching the product in the UK. The representative will require an official letter of designation to confirm the representative is entitled to represent a particular medical device manufacturer. Furthermore, the letter of designation needs to signify the names as well as contact details of both the parties - means the company and the representative.

The Detail of the Registration Requirements

The MHRA registration guidance also provides some additional clarifications regarding the particular cases in the registration with the regulating authority is required. The document also highlights certain important aspects related to each particular type of medical device, namely:

Custom Medical Devices

Whereas a tailor-made medical device under review is an implantable tool, the manufacturer or its representative need to submit complete instructions for using the device apart from the samples of its labeling.

System/Procedure Packs

The compulsory registration law involves business enterprises with a plan to promote their products in the UK. For having the registration, the applicant is supposed to employ the Global Medical Devices Nomenclature (GMDN) with a view to make sure the clearness of the product description. In addition, while submitting the application through the online procedure, the applicant company needs to use the GMDN terms that are stated in the guideline.

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