GRS News

We are thrilled to announce that Global Regulatory Services (GRS) has officially joined the UK Responsible Person Association (UKRPA). This significant step reinforces our commitment to providing our clients with industry-leading expertise in regulatory compliance, particularly in navigating the complexities of the UK medical device market post-Brexit. With this membership, GRS further strengthens its position as a trusted partner for manufacturers in the life sciences sector, helping them meet the UK's stringent regulatory requirements.

 

What is the UKRPA?

The UKRPA is a professional association created to bring together service providers who act as UK Responsible Persons (UKRP) under the UK Medical Device Regulations 2002, which came into effect post-Brexit. The UKRP plays a critical role in representing non-UK manufacturers who want to sell medical devices in Great Britain. This includes registering devices with the Medicines and Healthcare Products Regulatory Agency (MHRA), ensuring product compliance, and maintaining device records.

 

The UKRPA promotes best practices, transparency, and accountability within the industry, helping companies like GRS to stay ahead of the ever-changing regulatory landscape. By becoming a member, GRS aligns itself with a network of trusted professionals dedicated to ensuring the highest standards in medical device compliance.

 

Bobby Deal, Managing Director and Founder at GRS, emphasises, “Our membership in the UKRPA demonstrates our unwavering commitment to ensuring that manufacturers can confidently enter the UK market with the full support of a highly skilled and experienced team. We are proud to collaborate with other industry leaders to promote best practices and set the gold standard for regulatory affairs.”

 

 

The Importance of Appointing GRS as Your UK Responsible Person (UKRP)

 

Appointing GRS as your UKRP comes with multiple advantages. Our role ensures that your medical devices are registered with the MHRA, adhere to UK legislation, and are continually monitored for compliance. We manage all aspects of regulatory documentation, product labelling, and post-market surveillance. Our team of experts works closely with the MHRA to ensure that your products remain compliant throughout their lifecycle.

 

As the UK market presents its own unique challenges post-Brexit, having a knowledgeable and proactive UKRP like GRS can be the difference between successful market access and delays. We understand the nuances of UK legislation and offer tailored support that ensures smooth navigation of the regulatory framework.

 

Greer Deal, Director and Co-Founder of GRS, explains, “At GRS, we believe in offering more than just a service – we offer peace of mind. Manufacturers entrust us with the critical responsibility of ensuring their products are compliant, and we take that trust seriously. By joining the UKRPA, we are reinforcing our dedication to providing an unparalleled level of regulatory support.”

 

Highlighting GRS’s Regulatory Virtual Importer (RVI) Services

Alongside our UKRP services, GRS is proud to offer our Regulatory Virtual Importer (RVI) service, a vital asset for non-UK manufacturers. Our RVI service supports medical device and IVD manufacturers in meeting the UK's post-Brexit import requirements without relying on distributors for regulatory compliance. Acting as your RVI, GRS performs the role of an independent economic operator, verifying that devices meet UKCA or CE marking requirements, ensuring correct labelling, and facilitating compliance with UK regulations.

 

One of the key benefits of using GRS as your RVI is the ability to retain control over your supply chain. We maintain a direct line between you, the manufacturer, and the regulatory authorities, ensuring that all aspects of compliance are handled smoothly. This service is particularly valuable for companies looking to reduce risks associated with relying on third-party distributors for regulatory compliance.

 

Greer Deal notes, “The post-Brexit landscape can be daunting for manufacturers, but with GRS as your RVI, we streamline the entire process, allowing companies to focus on innovation while we handle the regulatory complexities. Our approach is proactive, meaning we don’t just react to regulatory changes – we anticipate them, ensuring our clients stay one step ahead.”

 

 

Why Choose GRS as Your UKRP and RVI?

By choosing GRS as both your UK Responsible Person and Regulatory Virtual Importer, you benefit from a holistic, integrated approach to regulatory compliance.

 

We offer:

• Comprehensive Regulatory Expertise: Our team of specialists has in-depth knowledge of both UK and EU regulations, ensuring your products meet the necessary standards for both markets.
• Proactive Compliance Management: With GRS, you can trust that all regulatory aspects of your products are continuously monitored and updated in line with evolving UK legislation.
• Tailored Solutions: We understand that every manufacturer’s needs are unique. GRS provides bespoke support, adapting our services to align with your specific product portfolio and business goals.
• Independent and Transparent Oversight: Acting as your UKRP and RVI, we ensure full regulatory oversight, maintaining an independent position that allows us to advocate for your products without conflict of interest.
• Streamlined Processes: With our efficient systems in place, we ensure that your regulatory documentation, product registrations, and market surveillance are managed seamlessly, allowing you to focus on what you do best – developing innovative medical technologies.

 

Bobby Deal sums it up, “GRS is more than a regulatory service provider – we are your regulatory partner. Our dual role as UKRP and RVI means we handle every aspect of your compliance needs, offering peace of mind that your products are in safe hands. With our membership in the UKRPA, we are more equipped than ever to deliver world-class regulatory solutions to our clients.”

 

Join Us on the Path to Regulatory Excellence

At GRS, we are excited to leverage our UKRPA membership and RVI services to help manufacturers navigate the post-Brexit regulatory environment. Whether you're looking to enter the UK market or ensure ongoing compliance, GRS is your trusted partner for success.

 

For more information on how GRS can support your regulatory needs, contact us today. Let us help you turn regulatory challenges into opportunities. Drop us an email at – grs@globalregulatoryservices.com or submit a web form via - https://globalregulatoryservices.com/global-regulatory-services-contact-details