Navigating EU Medical Device Regulations: Understanding The Impacts And Ensuring Compliance For Integral Combination Products

EU Medical Device Regulation (MDR) applies to all medical device manufacturers who intend to place their medical devices on the European market. Over the years, MDR changes have substantially altered the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product's lifecycle. MDR modifications initiated in 2017, expanded the category of products classified as medical devices.

This means pharmaceutical companies filing in the EU are required to show compliance to MDR 2017/745 Annex I General Safety & Performance Requirements for integral combination products, such as prefilled syringes (PFS). In the EU, drug-device combination products that combine a medical device with a medical product, can be regulated as either a medicinal product or a medical device.

West has created a technical documentation package (TDP) to support your navigation of these new document requests. The TDP provides customized information, which helps you easily locate and extract the information needed to support your EU MDR filing process. With direct referencing to Annex I GSPRs, this document will help you minimize the complexity of the entire process.

In this webinar, we review the MDR changes, specifically with respect to integral combination products such as pre-filled syringes, and we examine the TDPs supporting functionality and content.

Key Takeaways:

• Overview of new changes in Medical Device Regulations
• Understanding impact to integral combination products, such as Pre-Filled Syringes
• Understand the value of the Technical Document Package to support EU filings