Established In 2006
Competitive Prices
Experts in Certification
EU Authorised Representative & Responsible Person Specialists. Since 2006, We Have Provided Expert Compliance Services At Competitive Prices, Helping Manufacturers Achieve Fast And Reliable EU Market Access Worldwide.
EU Authorised Representative Services
- Also known as an EC Rep, EU AR or EU Rep. For non-EU based medical manufacturers it is mandatory to appoint an EU Authorised Representative.
- Registration with EUDAMED is required for all non-EU medical device manufacturers.
EU Authorised Representative for Medical Devices
- Business name and address required for surveillance purposes as identified in Article 4, paragraph 5 of the legislation.
- Under the Market Surveillance legislation EU 2019/1020 released in July 2019, all items falling under the scope of union harmonisation legislation will need to have an EU economic operator.
EU Authorised Representative
- For products that do not fall under any specific legislation, the EU General Product Safety Regulation 2023/988 (GPSR) is there as a catch-all.
- Products within the scope of EU GPSR do not require the CE Mark but since the regulation came into place on 13th December 2023, manufacturers do require an EU responsible person.
EU GPSR Responsible Person
BESPOKE FOR YOU
Our Services
We help not just UK-based manufacturers, but manufacturers based in other countries outside of the EU comply with the legal obligations of selling into the EU by providing the EU Authorised Representative / EU Responsible Person Service. In the context of product compliance, an EU Authorised Representative (EUAR) is an individual or a business entity that acts as an authorised point of contact on behalf of a manufacturer that is based outside of the country for which the product is being sold.
About Us
We had limited time for our products CE marking for the EU market. John and Mark were able to accommodate us at late notice and with their expert knowledge and skills from Mark and everyone at Product Approvals, we were able to certify our product on time and professionally.
Claudia Forsbrey – Project/Account Manager
To say that I am impressed by your recent performance and help in testing is a complete understatement, you have vastly exceeded my hopes and expectations and your efficiency and speed have been of invaluable help to my Company, many thanks indeed.
Dr Robert Vaughan.
I just wanted to send you an email to say thank you for the great service that PA ltd has been providing us with.The compliance and technical support service we have received has been excellent with all work being undertaken both diligently and thoroughly.
Jay Davies(Product Integrity Manager)
Reviews
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Address
Suite C2, Coalport House, Stafford Court, Stafford Park 1, Telford TF3 3BD, UK