PMCF plan is a continuous process updating clinical evaluation for CE-marked medical devices. Plan must confirm safety, performance, and identify unknown side-effects. PMCF findings must be documented in evaluation report. Plan adequacy subject to assessment by notified body
This guidance is not legally binding but represents best practice. MDR allows using clinical data from equivalent devices for CE marking. Guidance covers demonstration of equivalence for existing market devices
CE marking indicates product conformity with European health, safety and environmental standards. Required for goods sold in European Economic Area (EEA). Not a quality indicator or certification mark. Must be affixed by manufacturer or authorized representative
Regulation aims to harmonise in vitro diagnostic medical devices market. Replaces Directive 98/79/EC and Commission Decision 2010/227/EU. Focuses on high safety and health protection while supporting innovation
Directive harmonizes pressure equipment laws across EU member states. Applies to equipment with maximum pressure PS greater than 0.5 bar. Covers both new and imported pressure equipment and assemblies. Excludes pipelines, water networks, simple pressure vessels, aerosol dispensers
EN 1090 regulates execution of steel and aluminium structures. Standard divided into three parts: EN 1090-1, EN 1090-2, and EN 1090-3. Applies only to construction products not covered by harmonised standards