Authorized representative
What is an EU(UK) Authorized Representative
An EU(UK) Authorized Representative is any natural or legal person established within the EU(UK) who has received and accepted a written mandate from a manufacturer located outside the EU(UK), to act on the manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under the EU(UK) Regulations.
Why you need an EU(UK) Authorized Representative
a. According to Medical Device Directive 93/42/EEC and the MDR 2017/745(UK MDR 2002), a manufacturer outside EU(UK) must designate an EU(UK) Authorized Representative to place medical devices in the EU(UK) market.
b. On June 25, 2019, Regulation (EU) 2019/1020 on market surveillance and compliance of products was published in the Official Journal of the European Union.
The Market Surveillance Regulation prohibits the placing on the market of certain goods unless an economic operator established in the EU is identified as responsible for ensuring the availability of the conformity documentation, cooperating with market surveillance authorities and informing authorities when they have reasons to believe that a product presents a risk. This can be:
1.a manufacturer established in the Union;
2.an importer, where the manufacturer is not established in the Union;
3.an authorised representative
4.a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union.
Our services
1. Medical device registration
2. Registered address within the EU
3. Assess technical documentations and declaration of conformities
4. Keeping all technical documents at the disposal of authorities
5. Assist with complaint handling, vigilance reporting and field safety corrective actions
6. Act as primary contact point for authorities and distributors
7. Consulting on European device regulations
8. Monitoring changes to the EU regulations and keeping manufacturers updated
An EU(UK) Authorized Representative is any natural or legal person established within the EU(UK) who has received and accepted a written mandate from a manufacturer located outside the EU(UK), to act on the manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under the EU(UK) Regulations.
Why you need an EU(UK) Authorized Representative
a. According to Medical Device Directive 93/42/EEC and the MDR 2017/745(UK MDR 2002), a manufacturer outside EU(UK) must designate an EU(UK) Authorized Representative to place medical devices in the EU(UK) market.
b. On June 25, 2019, Regulation (EU) 2019/1020 on market surveillance and compliance of products was published in the Official Journal of the European Union.
The Market Surveillance Regulation prohibits the placing on the market of certain goods unless an economic operator established in the EU is identified as responsible for ensuring the availability of the conformity documentation, cooperating with market surveillance authorities and informing authorities when they have reasons to believe that a product presents a risk. This can be:
1.a manufacturer established in the Union;
2.an importer, where the manufacturer is not established in the Union;
3.an authorised representative
4.a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union.
Our services
1. Medical device registration
2. Registered address within the EU
3. Assess technical documentations and declaration of conformities
4. Keeping all technical documents at the disposal of authorities
5. Assist with complaint handling, vigilance reporting and field safety corrective actions
6. Act as primary contact point for authorities and distributors
7. Consulting on European device regulations
8. Monitoring changes to the EU regulations and keeping manufacturers updated