Eu registration and EU market regulation for medical devices and in vitro diagnostics as well as personal protective equipment

Eu registration and EU market regulation for medical devices and in vitro diagnostics as well as personal protective equipment

Categorize your products

Selection of notified body

Compile a list of required documents

Create these documents (e.g., technical documents)

Communicate with notified bodies

Choose a lawyer when a dispute arises

Check documents before submission

To be your EU representative

Registered product

Expanding business opportunities in the EU market
Eu authorized representative

EU-Representative is the authorized representative of the European Union, also known as the Representative of the European Union. Means a natural or legal person specifically designated by a manufacturer located outside the EEA(including EU and EFTA). The natural or legal person may act on behalf of a manufacturer outside the EEA to perform the specific duties required of the manufacturer by the relevant directives and laws of the European Union. The EU authorised representative is responsible for the registration of products in the European contract and the regulation of the EU market.
Responsibilities of authorized representatives of the European Union

Manufacturers outside the EU appoint an Authorised Representative (" Authorised Representative ") based in all 30 EU +EFTA Member States to represent manufacturers outside the EU in dealings with governments and institutions in all 30 European countries.

The name and address of the manufacturer's EU authorized representative/EU representative (EU authorized agent) must be clearly printed on the packaging, labels and instructions of products imported from outside the EU with the CE mark.

The "Technical documents" must be stored with the authorized representative/Representative of the European Union (EU Authorized Agent), and the authorized representative/Representative of the European Union (EU Authorized agent) must keep the latest "Technical Files" of all products bearing the CE mark. According to EU law, ensure that it can be provided to the CE supervision authority in the EU at any time and in a timely manner. After the last batch of products is placed on the market, its technical documentation shall be retained with the EU Authorised Representative/EU Representative (EU Authorised agent) for at least 10 to 15 years according to the classification of the product.

To establish an "Accident prevention surveillance system", manufacturers outside the EU must establish an effective "accident prevention surveillance system" in the EU, through their EU authorized representative/EU representative (EU authorized agent) to provide assistance in incident reporting, notification, recall, etc.

The EU authorised representative may also, on behalf of the manufacturer, undertake an application for the registration of the device by the competent EU authority.

The EU authorised representative may also apply for a free marketing certificate for the manufacturer on its behalf.