European regulators have issued several new guidance documents relevant to medical device and in vitro diagnostic (IVD) manufacturers days before the In Vitro Diagnostic Medical Devices Regulation’s (IVDR) May 26, 2022 date of application.
The European Medical Device Coordination Group (MDCG) has targeted the following issues related to IVDR as well as Medical Devices Regulation (MDR) compliance:
- IVDR Article 110(3) transitional provisions regarding “significant changes” to device design and intended purpose (MDCG 2022-6)
- Q&A document on Unique Device Identification (UDI) requirements for devices under the MDR and IVDR (MDCG 2022-7)
- Applying IVDR requirements to legacy IVD devices (MDCG 2022-8)
- Summary of safety and performance (SSP) template for IVDR compliance (MDCG 2022-9)…
