Why MHRA Registration is Important for Medical Device Manufacturers

by Cert3 Global Cert3Global MHRA the acronym of the Medicines and Healthcare products Regulatory Agency, in the United Kingdom is basically a governing authority in the field of medical devices. It has recently published its guideline explaining the process of registration which is mandatory for businesses aiming to market medical devices in the marketplace of Great Britain and Northern Ireland.

So, if you are specializing in the manufacturing and marketing of medical devices and aim to launch your product in the above-stated markets, make sure to go through this article. It informed the latest version of the guidelines published by the authority so that you can get MHRA registration right away to make your venture successful.

As per the applicable regulation, registration will be required for:

•    All kinds of the medical device fall under Class I,
•    Medical devices for In Vitro diagnostic,
•    Tailored-made medical devices,
•    Systems and processing parcels.

As stated by the authority manufacturers and marketers of medical devices and things of the above categories having the intention to sell their product in Great Britain must stick to the regulatory necessities as explained by the regulations 2002 of Medical Devices (UK MDR 2002) to be eligible for registration. On the other hand, for medical devices that are planned to be marketed in Northern Ireland, different regulatory requirements may be applicable.
 
In addition, the MHRA also emphasizes that such applications for getting registration of different medical devices need to be submitted by local units of the manufacturer or by a UKRP stands for UK Responsible Persons. This rule is applicable to all overseas medical device manufacturers.

It is also stated in the rule that the applicant will be absolutely responsible in terms of the accuracy and trustworthiness of the details of the information submitted. The governing authority also holds the right to ask the applicant to furnish further technical details and data (documentation and information)that are judged judiciously necessary for demonstrating the medical device that comes into question to ensure that it complies with regularity requirements formulated in UK MDR 2002.

The Registration Detail

According to the applicable legislation, a manufacturer of medical devices,the authorized representative of the company is required to notify the authority before manufacturing its product which will be marketed to healthcare centers, physicians, and patients located in the UK. This condition is applicable for both new as well as renovated medical devices of all categories apart from the system or procedure packing in addition to tailor-made medical devices.

It is worth noting for foreign medical device manufacturers with plans to market their product, which the very first step for them to go ahead is appointing a UK Responsible Person or UK-based authorized representative. The person will be appointed to represent the product manufacturer in each and every regulatory procedure linked with the medical devices to be marketed in this industry. After such an appointment, the manufacturer will have to communicate the complete details of the representative (UK Responsible Person of the company) to the governing authority.

However, distributors and suppliers of such medical devices are not obligated for applying for such registration.

Sponsor Ads

• Ad Space Available - Rent it Now!

Created on Nov 24th 2022 02:00. Viewed 211 times.

Comments