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Guidance document for the interpretation of significant changes in the framework of article 120

“Transitional provisions” of Regulation (EU) 2017/745

Article 120 of Regulation (EU) 2017/745 provides transitional provisions, including the possibility of maintaining until 27 May 2024, if certain conditions are fulfilled, the validity of the certificates of conformity with Directives 93/42/EEC and 90/385/EEC valid on 26 May 2020.

One of the main conditions to continue to place on the market or put into service a medical device covered by a valid certificate issued pursuant to Directives 93/42/EEC and 90/385/EEC is the absence of any significant change in the design and intended purpose of the medical device covered by the scope of this certificate.

To help you determine whether the change in the intended purpose or design of the device is a significant change referred to in Article 120 paragraph 3 of Regulation (EU) 2017/745, GMED published a guidance document for the interpretation of significant changes in the framework of article 120: “Transitional provisions” of Regulation (EU) 2017/745.

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