Why Do You Need An EC Representative?
Are you an overseas manufacturer and wish to promote your medical devices and IVDs in Europe? Did you know that in that case, you will have to appoint an EAR (European Authorized Representative before beginning your venture there?
It is worth noting that the EU AR will act as the regulatory representative of your company in the European Market and will then be a point of contact between you or the manufacturing company and the European nation’s Competent Authorities.
The MDR/IVDR has augmented the account abilities of the EU AR. One important alteration involves the AR explicitly sharing the liability with the manufacturing company of the products on the market. Due to the importance of the AR’s role, it is vital to select a European Authorized Representative who will remain committed to acting as your partner in the entire market.
The EU AR is also referred to as an EC Representative or an Authorised Representative.
If you are wondering about the responsibilities of the Authorized Representative, you need to note that apart from acting as a link with the European Competent Authorities, the European Representative is responsible for the following purposes.
Verifying that the details of technical documentation of the manufacturer are drawn up according to the equivalent conformity process and preserving a copy of the technical specs file as well as a CE certificate for every device the company is likely to launch.
Verifying the EU declaration of the manufacturer’s conformity is aligned with the appropriate conformity evaluation procedure.
Checking that the producer complies with the UDI registration in accordance with Article 27 explained in the MDR, if applicable.
Providing authorization to embrace EU AR’s name as well as the address on the labeling of the manufacturer and other applicable documentation.
Executing an agreement with the manufacturing company to detail the obligations of either manufacturer as well as AR through the lifetime of the product in the EU market.
Reviewing as well as verifying your EUDAMED’S Registration Number application. The Relevant Authority will undergo the final review and equally issue you the SRN.
The representative will have to maintain a copy of every product that you launch technical documentation apart from CE certification. For non-implantable machinery, the EU AR should preserve technical details documentation for at least 10 years starting from the date of launching the product on the market arena. For implantable machinery, the AR needs to maintain the documentation for at least 15 years.
Informing the producer if any type of complaint is raised from the healthcare providers or patients and will be liable to support the FSCA or Field Safety Corrective Action (FSCA) reporting, in coordination with you as well as your importers as well as distributors.
Finally, you need to know that you will require a FSC that stands for Free Trade Certificate which is used as an international export documentation for exporting medical devices as well as IVD medical products. It shows that the products you deal in can be marketed in European countries freely.
View Source: https://medium.com/@freesalescertificate/why-do-you-need-an-ec-representative-1d95fabe7118
