The Medical Devices Coordination Group (MDCG) has issued a guidance on Article 5(5) of the Medical Devices and In Vitro Diagnostics devices regulations. Thus, this document’s scope concerns medical devices manufactured and used within EU health institutions (referred to as in-house devices) to assess the needs of target patient groups that cannot be met by an equivalent CE-marked device available on the market. In this respect, these devices are exempted from the conditions in MDR & IVDR and are regulated by the rules set in Article 5(5) of those Regulations. It is worth noticing that custom-made devices are not included in the definition of an in-house device and are not subject to Article 5(5) MDR/IVDR.
Therefore, the guidance provides clarification on concepts as for example what is a health institution, an in-house device, and, most importantly, provides guidance on terms used in Article 5(5) MDR/IVDR, such as:
- Which devices are referred to in Article 5(5)?
- How to understand the terms “manufactured and used”?
- The concept of a legal entity
- What is an appropriate quality management system?
- What kind of information can be requested from health institutions by competent authorities?
Furthermore, it also describes the requirements health institutions must ensure for the meeting of their in-house devices with the relevant general safety and performance requirements:
- The establishment of a risk management system and the regular update of the benefit-risk ratio assessment;
- Requirements regarding design, manufacture and performance of devices;
- Requirements for the information that is supplied with the device;
It also provides indications on the justification 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 on the market and other topics. Finally, its annexes include a public declaration on the manufacturer of use of in-house devices by health institutions and a timeline for applying different Article 5(5) IVDR provisions.
Find all relevant Guidance documents in our Library of Documents.