13.01.2023
For the attention of healthcare professionals and researchers in healthcare institutions who intend to design, manufacture, modify and use in-house devices and all interested parties in the field of medical devices
Please be informed that, on 10 January 2023, the European Commission published the MDCG 2023-1 guidance: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 intended for in vitro diagnostic medical devices (IVDR).
Medical devices can be manufactured and used within EU healthcare institutions (in-house devices), on a non-industrial scale, to meet the specific needs of target patient groups that cannot be met or cannot be met at the appropriate level of performance, by an equivalent CE marked device available on the market.
Medical devices manufactured and used only within healthcare institutions (in-house devices) are exempt from most of the provisions of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), provided that the healthcare institution complies with the conditions set out in Article 5 paragraph (5) of the Regulation.
In order to ensure the highest level of health protection, Article 5(5) lays down a number of rules concerning the manufacture and use of such in-house medical devices.
The provisions of Article 5(5) underlie the regulatory control and surveillance of in-house devices. This document provides guidance on the application of some of these rules.
Moreover, this guidance intends to encourage the harmonised application of Article 5(5) by national competent authorities.
Both Regulations also specify that any physical or legal person offering diagnostic or therapeutic services through distance sales to patients in the European Union must use devices which are compliant with the MDR or IVDR (Article 6 paragraph (2)). Please note that the provision for derogation from Article 5 paragraph (5) applies only to healthcare institutions in the EU.
While most of the recommendations in this document relate to both medical devices and in vitro diagnostic medical devices (IVDs), some are specific to IVDs; such cases are explicitly mentioned.
Regulation (EU) 2022/112 postponed the application of some, but not all, provisions for in-house IVDs. A schematic presentation of the moment of application of provisions of article 5 paragraph (5) of the IVDR can be found in Annex B to this guideline.
Please note that the corresponding Article 5(5) of the MDR is already fully applicable from 26 May 2021.
The European Commission announcement is available here: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf
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