Clinical Evaluation Report (CER)
The EU MDR 2017/746 and UK medical device regulations require manufacturers to maintain an up-to-date Clinical Evaluation Report (CER) as part of their technical documentation to obtain CE or UKCA marks.
A CER systematically assesses clinical data to demonstrate safety and performance. It supports regulatory compliance and ensures the medical device conforms to essential requirements.
Trusted by top-tier teams worldwide
Apotech can support with:
- Clinical scope, context, and state-of-the-art assessment
- Device description and development history
- Risk management alignment
- Clinical evaluation methodology
- Literature search execution
- Analysis of safety and performance data
Featured case studies
EU-MDR Technical File Authoring
EU-MDR Technical File Authoring Introduction Medical Technology Client Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices. Apotech Consultants Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your…
A genetic testing kit manufacturer Journey to UKCA Marking with Apotech
Introduction The client In response to the UK’s new post-Brexit regulatory requirements, our client, an innovative genetic testing kit manufacturer, collaborated with Apotech to achieve UKCA marking. This strategic move was aimed at maintaining their market presence in the UK, ensuring uninterrupted access for their cutting-edge products. Types Scope of work Apotech provided end-to-end support…
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…