Cybersecurity requirements under the EU Cyber Resilience Act (CRA)
At the end of 2024, the EU Cyber Resilience Act (CRA) came into force, with the aim of improving cybersecurity of digital products on the European market. These new requirements will be mandatory in steps starting from September 2026.
As a manufacturer or importer of connected electrical products in the EU, this means you need to review and update your processes, systems, applications, products and services starting with incident and vulnerability reporting by September 2026 and fully compliant by December 2027. Is your the product in its current form compliant? You may need to modify the design and system functionality, or even organizational process? In addition, you will need to update your technical file with proof of compliance. Familiarize yourself with these new requirements now!
From the program
- Overview of Global and EU Cyber Security regulations context
- EU CRA requirements overview and announced updates
- Vulnerability and incident reporting
- Products in scope and their categorization
- The route to compliance
- The EU concept of “Placing on the market”
- We clarify when you need to use a certification body
- Necessary technical documentation
- Status of applicable standardization and overview of available standards
- Principle descriptions for conformity
- Recommended Way Forward
Course objectives
After the course you will be well acquainted with the requirements in CRA and the steps you can take to assure compliance.
Who should take the course?
This course is mainly aimed at those working with development and regulatory compliance of connected products. In addition, it may be useful for quality managers or regulatory affairs professionals.
Prerequisites
No need for pre-knowledge.
Course language
English
Please note:
Intertek operates under strict standards of independence, impartiality, and integrity. Read more about how we work here: https://www.intertek.com/about/compliance-governance/
Course Leaders
Shiva Mokhberi
Cyber Security Evaluator
Shiva Mokhberi is an experienced technical expert in the life sciences and medical device industries, with a strong background in regulatory compliance, product testing, and global market access. She leads and supports testing projects for a wide range of medical devices and laboratory equipment in accordance with key international standards, including IEC 60601-1, IEC 61010-1, ISO 14971, IEC 62366, IEC 62304, and IEC 81001-5-1. She also participates in SIS TK318 AG 61 (product cybersecurity).