WHAT DO YOU HAVE TO DO TO COMPLY WITH THE REGULATION 2019/1020 ON MARKET SURVEILLANCE AND COMPLIANCE OF PRODUCTS? 

WHAT DO YOU HAVE TO DO TO COMPLY WITH THE REGULATION 2019/1020 ON MARKET SURVEILLANCE AND COMPLIANCE OF PRODUCTS? 

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

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

Fulfil 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.)

Fulfil 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.)

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All Right Reserved 2021 © Obelis Group

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Obelis Compliance Program for Online Sellers

Obelis Compliance Program for Online Sellers

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. 

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. 

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Important!

Important!

Designate an Authorized Representative

Designate an Authorized Representative

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

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

Designate a Person Responsible for Regulatory Compliance

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.

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.

You might also be interested in:

You might also be interested in:

  • Market surveillance national authorities are empowered to ensure manufacturers fulfill their obligations.  
  • Market surveillance national authorities are empowered to ensure manufacturers fulfill their obligations.  
  • Key facts on EU Regulation 2019/1020
  • Who is concerned
  • How we can help you
  • Key facts on EU Regulation 2019/1020
  • Who is concerned
  • How we can help you

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

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: 

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

Avoid last-minute problems

You can demonstrate readiness for implementation of the Regulation and avoid difficulties connected with the last minute set-up.

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

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.

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

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.

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

Stay ahead of competition

Set yourself ahead of the competitors who have not yet designated an Authorized Representative.

Set yourself ahead of the competitors who have not yet designated an Authorized Representative.

What if you fail to comply?

What if you fail to comply?

Introduction to the Regulation

Introduction to the Regulation

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