IVDR vs. home-made methods

As the IVDR Regulation is written on 157 pages of juridical text where no one can find terms such as „home-made“ or „testing by non-CE IVD“, it may be useful to know paragraphs covering the topic. You can find them on page 18 and 19 of Official Journal of European Union (L117/194, dated 5.5.2017).

Generally, devices can be manufactured and used within health institutions only provided that „the health institution justifies in its documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market“. Briefly, it means that after May 26, 2022 (date of the end of simultaneous validity of both IVD Directive 98/79/EC and In Vitro Diagnostic Device Regulation (EU) 2017/746), usage of home-made devices for human laboratory testing is prohibited, if equivalent CE IVD kits are available on the market.

The other text of the above meant paragraph of the Regulation describes what a health institution must meet if an equivalent device is not available on the market. These requirements will make any „home-made“ manufacturing very difficult.