Certification to MDR (EU) 2017/745

Significant changes according to the Medical Devices Regulation (EU) 2017/745 Article 120 (3)

As in the past, the relevant change notifications for planned significant changes after 26 May 2020 must be sent to us. We will evaluate them within the scope of our surveillance obligations in accordance with Article 120 of the Medical Devices Regulation (EU) 2017/745 and will send you the result of this evaluation. Please consider that planned significant changes may only be implemented after approval by DEKRA Certification GmbH.

Significant changes according to the Medical Devices Regulation

As in the past, the relevant change notifications for planned significant changes after 26 May 2020 must be sent to us. We will evaluate them within the scope of our surveillance obligations in accordance with Article 120 of the Medical Devices Regulation (EU) 2017/745 and will send you the result of this evaluation. Please consider that planned significant changes may only be implemented after approval by DEKRA Certification GmbH.

If there is a significant change in design or intended use, it can only be evaluated after 26 May 2020 if your company is certified for this product in accordance with the Medical Devices Regulation (EU) 2017/745.

Please use for notification of planned significant changes the form F-091-27 which is available on the website.

After May 26, 2020, the following planned changes can still be evaluated and approved under further application of Article 120 MDR:

Changes to the organisational structure of the manufacturer e.g.

  • Change of name with legal succession
  • Relocation of the company's sites
  • Expansion with additional sites

Changes to the product, e.g.

  • Change of materials (e.g. change of suppliers)
  • Change of the expiry date of sterile products
  • Change of primary packaging / sterile packaging (where relevant for the safety of the medical device)
  • Changes of the software
  • Restriction of the intended use or indication
  • Addition of contraindications
  • Technically identical variants of the previously certified products (e.g. new product names, ...)

Changes in product realization, e.g.

  • Change in the manufacturing process
  • Change of supplier with identical material specifications
  • Change of contract sterilizer for the identical process
  • New cleanroom
  • Other manufacturing facilities or sites involved in the manufacture of the product
  • Changes resulting from decrees issued by authorities

After 26 May 2020, the following planned changes can only be evaluated and approved if your company is certified for this product in accordance with the Medical Device Directive (EU) 2017/745:

Changes to the design and intended use e.g:

  • Extension of the scope of application
  • New variants outside and within the confirmed parameter limits
  • Extension of indication/intended use

Team medical devices

DEKRA Team Medizinprodukte

separator
+49 711 7861-3771
separator
Share page