UKCA Marking Technical File Services for Medical Devices

Before a cosmetic product can legally be placed on the UK market, manufacturers and Responsible Persons must demonstrate that it is safe for human use under normal or reasonably foreseeable conditions. The Cosmetic Product Safety Report (CPSR) is one of the most important regulatory documents required under the UK Cosmetics Regulation. This guide explains what a CPSR is, who can prepare one, what information it must contain, how it relates to the Product Information File (PIF) and how it supports legal cosmetic compliance.

Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.

Scientific Validity is the first pillar of IVDR Performance Evaluation and provides the scientific foundation demonstrating that an analyte or biomarker is associated with a specific clinical condition or physiological state. This guide explains Scientific Validity under Regulation (EU) 2017/746, including literature reviews, Scientific Validity Reports, Annex XIII requirements, evidence appraisal and how Scientific Validity supports successful CE marking.

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.