Article 5(5) came into force on the 26th of may 2024 and considers several rules pertaining to the manufacturing and use of in-house medical devices, and the MDCG published its first Guidance of 2023 to guide and use the application of these rules.

With the exception of demonstrating conformity with general safety and personal requirements set out in Annex I, IVDR requirements do not apply to devices manufactured and used only within health institutions established in the Union, provided the conditions of Article 5(5) are met.

In this webinar, our SME, James Lappin, does a deep dive into the exemption provisions in Article 5(5) and discusses the following:

✅ What is the IVDR In-house exemption (Article 5(5))?
✅ How does it affect diagnostic testing in the EU, including local testing in clinical trials?
✅ What do you need to do to prepare?