It addresses the classifications and provides clarifications on the classification rules as set forth in Annex VIII of Regulation (EU) 2017/746. It is important to note that this classification advice also applies to diagnostic services provided to patients, information society services provided to them, and gadgets purchased online and placed into service.
Complete updates can be found on ISO - ISO Update
At the beginning of this year, the Commission filed with the Council and the European Parliament a proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 on the transitory arrangements for medical devices and in vitro diagnostic medical devices.
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