The EU Product Liability Directive 2024/2853 modernizes liability law for manufacturers, importers, and distributors – introducing new obligations, risks, and opportunities!

The areas of usability engineering, risk management, and design control are closely linked and overlap in some of their objectives and requirements.

A waiver of clinical data under MDR Article 61(10) is possible if the product’s nature, sufficient non-clinical evidence, and risk management justify it. Instead of clinical investigations, manufacturers may rely on technical testing, pre-clinical evaluation, and performance data to demonstrate safety and compliance.

This blog post highlights the latest changes in the MDSAP audit approach from version 008 to 009 and discusses the new features of the MDSAP AU P0037.002 document.