A major issue for healthcare providers is the application of Article 5(5) of the IVDR. The issue is that in many cases clinical laboratories, instead of using commercially available IVD devices, use devices that the laboratory manufactures or modifies itself or uses products intended only for research. Often because they cannot obtain the IVD devices needed for their patients on the market. But the most common reason is that "manufacturing" in a hospital laboratory is simply cheaper. That is, until Article 5(5) of the IVDR brought in the requirement to demonstrate safety and performance, as well as many other regulatory obligations.
Until recently, I thought that in the area of general medical devices and MDR regulation, Article 5(5) on in-house manufacturing of medical devices was not practically applicable. That swabs have stopped being wound up in the evenings on the nurses' station - and what else would be produced in a hospital? But no way! In an effort to "save money, whatever it costs", some hospitals are tendering for operating gowns by requiring compliance with the medical device standard EN 13795, but at the same time stating in the tender documentation that the product offered does not have to be a medical device.
This means that such a hospital knowingly purchases a 'semi-finished product' in the form of a generic product instead of medical devices for its operating theatres, and then assumes the obligations related to the 'commissioning' of such devices under Article 5(4) and (5) of the MDR. That is, it will itself assess compliance with the requirements of Annex I of the MDR and demonstrate compliance with the requirements set out in points (a) to (h). I think that most of the authors of these tenders do not understand at all what a "pack" they have created for their colleagues who will be responsible for compliance with the requirements for the so-called in-house devices and who will defend their documentation before the State Institute for Drug Control.
I can only recommend that before enforcing such a practice, they should talk to representatives of clinical laboratories or representatives of the Alliance for the Implementation of IVDR, who have long been working with the State Medicines Committee on how to manage the documentation requirements for in-house devices. I am curious to see how hospitals will comply with the notification requirement and publish a list of in-house manufactured garments for patients on their website. The justification required in Article 5(5)(c), i.e. that 'the specific needs ... cannot be met by an equivalent device already available on the market', will also be a big nut, if not an insoluble task. As can be seen, Article 5(5) is highly relevant in the scope of the MDR.
Author: Aleš Martinovský