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Medical Devices

Marketing of Medical Devices

According to Article 5 of the MDR and the IVDR, 'A medical device may be placed on the market or put into service only if it complies with the provisions of MDR 2017/745 or IVDR 2017/746', which requires economic operators, inter alia, to:

  • To comply with the obligations of the Regulation.
  • Implement a post-marketing follow-up and surveillance system.
  • To be evaluated by a Notified Body for CE marking (depending on the product).
  • Have technical documentation of the product in accordance with Annex II of the Regulation.

In Azierta we can help you in the elaboration of the documentation:

  • Implement the requirements of the new Regulations.
  • Of the post-marketing plan, which will include periodic safety and surveillance reports.
  • Updating of the clinical evaluation and post-marketing clinical monitoring.
  • Preparation of the technical documentation for the product.
  • Support with Notified Bodies.

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 2,000 clients

9 year experience

10 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

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