Helping Notified Bodies Meet Requirements

The New European Medical Devices Regulations

Since new European Medical Devices Regulations and In Vitro Diagnostic Regulations came into force, manufacturers have been updating their technical documentation and processes to satisfy the new requirements.

With the increased requirements on manufacturers to produce more clinical evidence for their products, demand has increased on Notified Bodies to assess clinical evidence robustly.

Guidehouse supports Notified Bodies by providing clinical expertise through an expert panel; supporting the review of manufacturers’ clinical evaluation reports for new CE marking, renewals, and spot audits of class IIb and class III devices; assisting with the evaluation of clinical trial data; published literature including systematic reviews and meta-analysis and real-world evidence; and providing internal training on understanding clinical investigations and medical statistics for technical reviewers.

Read three case studies that showcase how Guidehouse’s experts supported our clients through the regulatory and commercial development of all types of IVDs, companion diagnostics, medical devices, and combination products.


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