27 Apr Three reasons you should appoint an experienced UK Responsible Person 

For medical device manufacturers based outside of the UK, it has never been more important to choose the best UK Responsible Person (UKRP) to register the company’s devices with the MHRA before they are sold on the UK market.

In addition to acting as the manufacturer’s primary point of contact with the MHRA, the UKRP is responsible for ensuring that all technical documentation is properly prepared and informing the manufacturer of any complaints or adverse incidents that occur in the UK.

While a UKRP can be any third-party entity, such as an importer or distributor, who acts on behalf of the manufacturer, understanding the importance of the role and partnering with someone who has the necessary experience is critical,

The three key benefits to working with an experienced UKRP are:

Knowledge of MHRA requirements

It’s critical to check your technical paperwork and declaration of conformity for compliance. When you work with an experienced UKRP who has completed a number of projects in similar device classes, you can rest assured that the technical documentation they evaluate will meet MHRA regulations, and you’ll avoid filing applications that are incomplete or wrong.

Avoid multiple MHRA queries 

An inexperienced UKRP may fail to meet your deadlines, while submitting partial material or technical information in the wrong format can result in several queries. This will have an impact on the launch of your product in the UK market. You can avoid this by submitting an accurate submission first time.

Dealing with MHRA queries

It is the UKRP’s responsibility to reply to any queries after final submission to the MHRA. Minor inquiries can become huge ones due to a lack of experience dealing with comparable issues within your device class, causing a delay in releasing your product to the market.

With over 65 years of combined experience in the UK orthopaedics and spine markets, we are ideally positioned to be your UKRP and to assist you with the tasks required to market your medical device – device certification, device conformity, and MHRA registration, allowing you to enjoy a trouble-free and convenient service with reports on Alerts, recalls and safety information.

For hassle-free registration of your devices with the MHRA or to appoint Ortho Consulting Group as your UKRP, get in touch with us now or visit our dedicated UKRP page, here.

Keep up-to-date with all the latest UK Representative changes via the government website, here.