The Medical Device Coordination Group MDCG 2023-1 guideline has been published Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746at the conclusion of a long discussion in the Community context.
The (EU) 2017/745 Regulation relating to medical devices and the (EU) 2017/746 Regulation relating to in vitro diagnostic medical devices have introduced important innovations, with particular reference to devices that can be manufactured and used exclusively within of healthcare institutions in the European Union (“in house” devices), thus responding, on a non-industrial scale, to the specific needs of groups of patients that cannot be satisfied, with results of an adequate level, by an available equivalent CE marked device on the market. The conditions that the health institution will have to comply with are dictated by the requirements of Article 5(5) of the regulations in question.
The guideline is intended to support the uniform application of the requirements of article 5, paragraph 5 of the respective regulations by health professionals or by researchers of health institutions who intend to design, manufacture, modify and use devices “in house”.
The document includes definitions and examples with sections dedicated, among others, to the quality management system, the meaning of “specific needs of target patient groups”, the documentation supporting the need to make devices “in house” in the absence of CE marked equivalent devices.
The guideline, in Annex B, highlights the application of Article 5(5) of Regulation (EU) 2017/745 starting from 26 May 2021, while an application is envisaged for Regulation (EU) 2017/746 progressive over time.
For more information, consult the document