Published: 30 April 2021

In this issue

MDR Transitional Provisions

• Key Dates and Considerations
• Management of Legacy Devices  
• Preparing for May 2021

EU Cooperation and Guidance

• MDCG March Update
• Custom-Made Devices: Regulatory Considerations
• Carcinogens, Mutagens, & Reproductive Toxins: Rules and Regulations

HPRA Updates  

• IVDR Introductory Reference List for Class A Manufacturers
• HPRA’s Clinical Investigation Process
• Impact of Brexit on Medical Device Regulation