CE Marking Technical File Services for Medical Devices

More than half of IVDR submissions face deficiencies during Notified Body review, with Performance Evaluation Reports (PERs) among the most common areas of concern. Learn the three critical mistakes that lead to PER rejections—including weak State of the Art justification, non-systematic literature reviews, and poor traceability between Scientific Validity, Analytical Performance, and Clinical Performance data—and discover how to build a compliant, audit-ready IVDR technical file.

Preparing technical documentation for EU MDR or IVDR certification is only half the challenge. Successfully passing a Notified Body review depends on demonstrating consistency across your Quality Management System, Clinical Evaluation, Risk Management, Biological Evaluation, Performance Evaluation and Post-Market Surveillance activities. Discover ten of the most common technical documentation deficiencies identified during MDR and IVDR conformity assessments—and learn how to reduce the likelihood of costly review cycles and certification delays.

Selling medical devices or IVDs in Europe? If your company is based outside the EU, appointing an EU Authorised Representative (EC Rep) is a legal requirement under EU MDR 2017/745 and IVDR 2017/746. Patient Guard provides expert EU Authorised Representative services, EUDAMED support, regulatory guidance, and ongoing compliance management to help manufacturers access and maintain the European market with confidence.