DCB Newsletter #8/23: INSIDE DCB – Understanding the Regulatory Landscape

Do you already know all the services of DCB? With our Service Portfolio, DCB accompanies you on your entire translational journey. Would you like to conduct a study or research, but lack the appropriate premises and services? You might want to contact our regulatory experts for support.

Thank you Myriam Tinner and Stefanie Hossmann for your contribution.

Medical device regulatory affairs – a headache for start-ups?

Confronted with the complexity of the regulatory lanscape in the context of medical devices, first doubts could arise when realising an idea into a product,

Regulatory affairs in the context of medical device development refers to the process of ensuring that a medical device complies with all applicable regulations and standards set forth by regulatory authorities. It is a crucial aspect of bringing a medical device to market and maintaining its compliance throughout its lifecycle. For a startup in medical device development, understanding regulatory affairs is essential to navigate the complex landscape of regulations and ensure successful product development and market entry.

Here’s a breakdown of key elements involved:

• Regulatory Framework: What is needed for my medical devices in the target market?
• Classification: What is the classification of my medical device based on the intended use, the risk level and the impact on patient safety? The outcome determines the regulatory requirements and the conformity assessment process for my device
• Conformity Assessment; Identifying the applicable conformity assessment procedures
• Quality Management System (QMS); Implementation of a robust QMS to ensure compliance with regulatory requirements (my own or of a legal manufacturer)
• Clinical Trials; Defining if a clinical trial is needed and if so, to which extent
• Usability/Human Factors; Defining the inclusion of the target group into the development
• Regulatory Submissions; Preparing and submitting necessary documentation to regulatory authorities for approval or clearance to market my medical device
• Post-Market Compliance; Maintaining compliance through post-market surveillance activities

The highly experienced team at DCB is entangling the regulatory world for you. Are you looking for a specific answer or for assistance in developing your quality system according to ISO 13485? Or just a recommendation with whom to partner up? DCB’s support is tailormade according to your needs.

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Thanks for reading, dear community, and till next time. We’ll be back after the summer break!