The Need of EU Authorized Representatives for Asian Medical Device Manufacturers

Why is there a Need for EU Authorized Representative?

Appointing an Authorized Representative is necessary for non-EU-based medical device manufacturers. If a manufacturer does not nominate the Authorized Representative to repent him in Europe, the Notified Body will not issue him the CE certification. Moreover, every manufacture is also required to ensure the compliance of his product with the applicable Directive.

Without an Authorized Representative, the manufacturer will not be able to receive the CE certification. He will also fail in making his product compliant with the applicable Directive, resulting in his products being stopped at the border by the authorities.

Who Needs an EU Authorized Representative?

A medical device manufacturer looking forward to selling his products in the European market but does not have a physical presence in the continent requires an EU Authorized Representative. This EU Authorized Representative (also known as EC REP and AR) will represent his company to the European authorities.

What are the Roles of an EU Authorized Representative?

The most pivotal role of the EU Authorized Representative is that they represent a medical device manufacturer situated outside the EU in front of the National Competent Authorities (Ministries of Health). Other roles of this Authorized Representative are:

  • Providing assistance with device registrations
  • Getting identified on the manufacturer’s products’ labeling across all the EU
  • Making a current copy of the manufacturer’s Technical File or Declaration of Conformity so that the Competent Authority can inspect it upon request
  • Providing assistance in incident and Field Safety Corrective Action (FSCA) reporting in cooperation with manufacturer and his distributors.
Role of EU Authorized Representative Under EU MDR

Under EU MDR, the EU Authorized Representative will also be held responsible for any defective medical device, alongside the manufacturer.

Can a Medical Device Manufacturer Appoint a Distributor as EU Authorized Representative?

Appointing a distributor as EU Authorized Representative is allowed, but it is not recommended. This is because most distributors do not comply with the requirements of the EU Authorized Representative.

Therefore, the manufacturers should look forward to hiring an independent representative who has ample knowledge of regulatory affairs instead of marketing and sales.

What will be the Role of Authorized Representative after Brexit?

After Brexit, all the EU and non-EU companies looking forward to market their devices in the EU may need a UK-based Authorized Representative for this purpose. The same condition will apply for UK-based companies, which may require an EU-based Authorized Representative to sell their devices in the European market.

Is it Necessary to Mention the Name of the Authorized Representative on Medical Device’s Labelings, Packagings, and IFUs?

The manufacturer must display the credentials (name and address) of the Authorized Representative on the following:

  • Product label
  • The outer packaging
  • Instructions for Use.

The name and address must be displayed next to Authorized Representative’s logo.

Inspection of the Authorized Representative by the Competent Authorities

Competent Authorities can inspect authorized Representatives. This will help the Competent Authorities in determining if,

  • The Authorized Representatives have a complete understanding of their role
  • They have direct access to client documentation (Technical File/Design Dossier)
  • They have the correct processes in place to establish their role as the Authorized Representative.

Replacing of the Appointed Authorized Representative

A medical device manufacturer is allowed to change his Authorized Representative. This will not have any effect on the manufacturer’s product approvals. However, replacing the Authorized Representative can be costly, as the manufacturer will have to deal with the following two issues:

  • He will have to replace all the existing Authorized Representative’s logo with the new ones
  • He will have to deal with the products that have already been placed on the market.

Looking for someone to represent you in Europe?

Suppose you are an Asian medical device manufacturer looking forward to marketing your devices in the  EU. In that case, TSQ Asia and Middle East’s Authorized Representative can help you with all the required documentation, including labeling information, Technical files, symbols, language, directives, and guidelines, etc. With our premium expertise in European regulatory affairs, we can easily help you complete all the formalities, thereby ensuring a smooth registration process.

Share

Add Your Comments

Your email address will not be published.