What to do to comply with Regulation (EU) 2019/1020 on Market Surveillance and Compliance of Products?

What to do to comply with Regulation (EU) 2019/1020 on Market Surveillance and Compliance of Products?

As of July 16, 2021, you can only place a product on the EU market, if you:

  • Fulfill the essential requirements as stated by the legislation that applies to your specific product type; this has to be documented in the technical file (including the necessary testing etc.);
  • Designate an Authorized Representative established within the EU-27 who will be responsible to perform the tasks specified in the signed mandate as per the applicable EU legislation, for ex. keep available manufacturer’s technical documentation for inspections by the CAs.

Important!

Designate an Authorized Representative

  • Designation of the Authorized Representative must take place by signing a legal mandate (contract) by both parties.

Designate a Person Responsible for Regulatory Compliance

  • In addition for certain types of products, such as medical devices, it is crucial to designate a Person Responsible for Regulatory Compliance (PRRC), as well. That person must have the appropriate capabilities (resources, knowledge, competences, experience) to be able to fulfil their tasks.​

Why you should not wait till last minute to designate an Authorized Representative?

Designating an Authorized Representative is mandatory as of 16th July 2021. Today you can make this appointment on a voluntary basis. However, there are good reasons not to wait until the deadline:

  • Avoid last-minute problems: You can demonstrate readiness for implementation of the Regulation and avoid difficulties connected with the last minute set-up.
  • Authorized Representative agreement in place in advance: You can present a valid agreement with an Authorized Representative to Amazon and other interested parties, this will be requested way before the Regulation enters into force.
  • Build trust with your customers: You build up the trust in your products among your customers by showing you are step ahead of fulfilling all the regulatory requirements.
  • Stay ahead of competition: Set yourself ahead of the competitors who have not yet designated an Authorized Representative.

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