The driving forces for an extensive overhaul of the medical device and in vitro diagnostic industries in Europe, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/46 (IVDR), have increased the cost and complexity of keeping existing products on the market and introducing new technologies.

The unforeseen impact of the global COVID-19 public health emergency has hampered implementation activities, leading to a series of interim actions and amendments to ensure continued access to life sustaining and life saving medical devices and in vitro diagnostic products.

Facing the likelihood of shortages, a proposal to extend the MDR transition periods took effect on 20 March 2023. This regulation is a targeted amendment which extends the transition period for the MDR to 31 December 2027 and 31 December 2028 depending on the device risk class, provided certain conditions are met. Medical device and in vitro device manufacturers should familiarise themselves with the eligibility requirements for the recent extension.

Read this briefing document to:

• Understand the MDR amendment, including transition period extension and conditions
• Review the current status of IVDR
• Learn about notified body status and certification progress
• Explore recent non-legislative actions related to MDR and IVDR implementation