EU Regulations

Performance Evaluation is one of the most important requirements under the EU In Vitro Diagnostic Regulation (IVDR). Every manufacturer must demonstrate that their in vitro diagnostic medical device achieves its intended purpose through robust scientific validity, analytical performance and clinical performance evidence. This guide explains every stage of IVDR Performance Evaluation, including Performance Evaluation Plans (PEPs), Performance Evaluation Reports (PERs), Post-Market Performance Follow-up (PMPF) and how Performance Evaluation supports successful CE marking under Regulation (EU) 2017/746.

Understanding how your in vitro diagnostic device is classified under the EU IVDR is one of the first and most important steps towards regulatory compliance. This guide explains the IVDR classification rules, the differences between Class A, B, C and D IVDs, how Annex VIII is applied, and how classification affects conformity assessment, technical documentation and Notified Body involvement.

A material change, supplier switch, manufacturing transfer or design modification does not automatically require new ISO 10993 biocompatibility testing. Learn how manufacturers use Biological Evaluation Plans (BEPs), chemical characterisation, toxicological risk assessments and Biological Evaluation Reports (BERs) to determine whether existing biological evidence remains valid or whether additional testing is required under ISO 10993-1, the EU MDR and FDA expectations.

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.