GRS News

In just over 3 months Brexit will happen. Are UK MedTech manufacturers ready? This webinar on Wednesday 30th September (11:00 to 12:00) will highlight challenges and provide solutions.  By investing one hour of your time, you could well be securing the future success of your company in Europe.

Join Greer Deal of Global Regulatory Services and Dr Kieran Connole from Med-Di-Dia for an event focused on UK MedTech manufacturers. The United Kingdom's relationship with the European Union is changing so it is essential the UK MedTech manufacturers know how to adapt to these changes to keep their product on both the EU and UK markets. During this webinar, the presenters will outline the challenges for UK based companies and how to overcome them.

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With the introduction of the new Medical Device and In-Vitro Diagnostic Regulations, the current regulatory landscape is causing MedTech companies to reassess their product portfolios. A further complication for UK based MedTech manufacturers, however, is the loss of ready access to the European market from the 1st January 2021. This will have a significant impact on UK companies' access to the European market. This webinar will:

• Outline what urgent steps are required by UK manufacturers to be Brexit-ready
• Confirm how to legally keep devices on the European market post-Brexit
• Establish what the supply chain will look like from January 2021 and the separate regulatory obligations for companies supplying devices into Europe
• Outline the Roles and Responsibilities of the individual Economic Operators in Europe and the UK, including UK Responsible Person
• Provide an overview of the future plans for medical devices and in-vitro diagnostics in the UK under the MHRA and its impact on UK MedTech manufacturers

Global Regulatory Services (GRS) is a well established, award-winning global regulatory and quality compliance consultancy with in-country expertise as well as regulatory and technical know-how. In July 2019, Med-Di-Dia was spun-out of GRS to focus on providing regulatory advice and support to the MedTech industry. This sister organisation supports Medical Device, In-Vitro Diagnostic and Digital Healthcare companies from their base in Galway, Ireland. They offer a full range of services under the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), including EU Authorised Representative, for companies placing their products on the European market from small start-ups to multinationals. GRS and Med-Di-Dia have the capability to fully support both the EU and UK markets ensuring full compliance post-Brexit. For companies looking to enter the US, Canada and Rest of World markets they offer regulatory and compliance services bespoke to the needs of the client.

Yes, I'd like to register