Explore how our UK Importer Services can help medical device manufacturers navigate post-Brexit regulations. At Cert 3 Global, we’re here to guide you through compliance with UKCA marking and MHRA registration, making your entry into the UK market hassle-free.
Are you a medical device manufacturer seeking to introduce your product to the UK market?
With Brexit’s arrival, the UK can no longer follow European medical device regulations, rendering EU MDR and IVDR obsolete. Adhering to the prevailing UK Medicines and Medical Devices law is now essential.
Why Choose a UK Importer Service
UK regulations mandate the engagement of an importer familiar with compliance for shipping to Great Britain, including England, Scotland, and Wales.
Cert 3 Global: Your Trusted UK Importer Service
At Cert 3 Global, we’re renowned for our expertise as holders of a Great Britain import license.
Access Reliable Services:
Benefit from our expert UK Importer services at a competitive price. Contact us today. We specialize in EU and Swiss imports, offering seamless compliance evaluation to kickstart your UK operations.
Our Comprehensive Services Include:
Assessing device compliance with the UKCA mark.
Verifying UK declaration of technical documentation and conformity
Checking labeling, IFU, and UDI information.
Ensuring the producer is recognized and assigned a UK Responsible Person.
Maintaining complaint records as per UK law.
Confirming compliance with MMDA storage and transportation requirements.
Alerting manufacturers to non-conformity risks.
Verifying device registration with MHRA.
Reporting risks and incidents to MHRA and collaborating on CAPA issues as your trusted UK import license holder.
