The UKCA marking came into effect on January 1, 2021. iCertifi can help identify the UK status of your device, perform a gap analysis of Statutory Instruments and Standards and provide you with an Authorized Representative in the UK.
What is the role of the UK Authorized Representative?
To be eligible for appointment as an Authorized Representative in the United Kingdom market, an applicant must be a legal entity in the United Kingdom. iCertifi offices in the Scotland will act as a liaison between a manufacturer outside the UK, ensuring the products being sold comply with the most current regulations.
The manufacturer and the authorized representative must keep documentation to demonstrate that the product conforms with the regulatory requirements in the form of a technical file, which must be retained for up to 10 years after the product is placed on the market. This information can be requested at any time by market surveillance or enforcement authorities to check that your product conforms with the statutory requirements.
The Authorized Representative will be the legal representative for the device(s) and for the device manufacturer to the UK authorities The Authorized Representative will be the first and only entity the government will interface on regulatory and potential recall issues. Lastly, any fines for non-conformance will be levied onto the Authorized Representative.
iCertifi UK Authorised Representative Services
- Technical File Review
- Review of all documents and reports associated with the technical file of the products to be introduced into the UK market.
- Assessment
- Compare reports to the most current standards the products must comply to and create a Gap Analysis of any deficiencies in the documents.
- Technical File Updating
- iCertifi can work with your preferred lab to ensure the reports are updated to the most current standards and to mitigate other deficiencies in the Gap Analysis report.
- Authorised Representative Contract
- Once the technical files have been assessed and corrected, iCertifi will act as the Authorized Representative United Kingdom for the period of 10 years.
- TCF Storage
- Technical files will be stored for 10 years in iVault, our proprietary document and certificate repository. iVault gives you access to your files through a secure portal login.
Through the use of iCertifi’s UKCA Authorized Representative services, you will feel confident knowing that your products have been reviewed by our technical file experts. Whether you are selling electronics, industrial machinery or medical devices, we will ensure your products are complaint with current UK Regulations.