On December 15, 2021, the European Commission published in the Official Journal the Implementing Regulation (EU) 2021/2226 on rules for the application of Regulation (EU) 2017/745 regarding electronic instructions for use of medical devices.
This implementing regulation enters into force on the twentieth day following publication in the OJEU and sets out the requirements that will need to be put in place by manufacturers in response to the requirements of Regulation (EU) 2017/745 regarding the provision of instructions for use in electronic format.
Regulation 207/2012 is repealed. However, it remains applicable for medical devices subject to Article 120 of Regulation (EU) 2017/745 until the end of validity of certificates issued under Directives 90/385/EEC and 93/42/EEC.
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