Current English catalogue

Guidance topics

Browse 156 guidance entries across 62 reviewed topics. Body-only suggestions that have not been approved are not published here.

• 3D printing1 guidance entryConformity assessment for 3D printing and 3D-printed medical products.
• Annex XVI products3 guidance entriesProducts without an intended medical purpose covered by MDR Annex XVI.
• Artificial intelligence1 guidance entryInterplay between medical-device legislation and the EU Artificial Intelligence Act.
• Authorised representatives3 guidance entriesAppointment, responsibilities, and oversight of authorised representatives.
• Basic UDI-DI2 guidance entriesAssignment and change rules for Basic UDI-DI.
• Borderline regulatory status5 guidance entriesDetermination of whether a product falls within medical-device legislation or another regulatory framework.
• Breakthrough devices1 guidance entryEU guidance or pilot pathways for breakthrough devices.
• Certification and certificates9 guidance entriesCertification activities, certificate content, transfer, and transitional certification.
• Class I devices1 guidance entryRegulatory requirements for Class I medical devices.
• Clinical and performance evidence18 guidance entriesUmbrella category for clinical investigation/evaluation and IVD performance studies/evaluation.
• Clinical evaluation6 guidance entriesClinical evaluation of medical devices under the MDR.
• Clinical evidence2 guidance entriesSufficiency and general principles of clinical evidence.
• Clinical investigations9 guidance entriesPlanning, conduct, reporting, modification, or submission of MDR clinical investigations.
• Conformity assessment10 guidance entriesConformity-assessment procedures for devices and related products.
• Corrective and preventive action (CAPA)1 guidance entryCAPA plans and their assessment for notified-body/designating-authority processes.
• COVID-1913 guidance entriesMedical-device guidance issued in the COVID-19 context.
• Custom-made devices1 guidance entryRegulatory requirements for custom-made devices.
• Cybersecurity1 guidance entryCybersecurity requirements and practices for medical devices.
• Device classification8 guidance entriesClassification rules and classification decisions under MDR or IVDR.
• Device Specific Vigilance Guidance (DSVG)6 guidance entriesDevice-specific vigilance guidance and templates.
• Economic operators3 guidance entriesObligations of manufacturers, authorised representatives, importers, and distributors.
• Equivalence3 guidance entriesUse and demonstration of equivalence for clinical evaluation or Annex XVI products.
• EUDAMED7 guidance entriesRegistration and operational use of the European Database on Medical Devices.
• European Medical Device Nomenclature (EMDN)12 guidance entriesUse, revision, and governance of EMDN nomenclature.
• Expert panels1 guidance entryConsultation or scrutiny involving expert panels.
• Hazardous substances (CMR and endocrine disruptors)1 guidance entryHazardous substances in medical devices, including carcinogenic, mutagenic, or toxic-to-reproduction substances and endocrine disruptors.
• Implant cards2 guidance entriesImplant-card content and application requirements.
• Importers and distributors3 guidance entriesRegulatory obligations of importers and distributors.
• In vitro diagnostic devices (IVD/IVDR)43 guidance entriesRegulatory requirements specific to in vitro diagnostic medical devices.
• In-house devices1 guidance entryHealth-institution exemption and in-house device manufacture/use.
• Interruption or discontinuation of supply5 guidance entriesNotification obligations when supply of devices is interrupted or discontinued.
• IVD classification2 guidance entriesClassification and qualification of in vitro diagnostic devices.
• Labelling and language requirements2 guidance entriesLanguage, symbol, relabelling, and information-supply requirements.
• Legacy devices and transitional provisions15 guidance entriesTransitional provisions and surveillance/certification of legacy devices.
• Master UDI-DI3 guidance entriesImplementation of Master UDI-DI solutions for specified product groups.
• Medical Device Single Audit Program (MDSAP)1 guidance entryUse of MDSAP audit reports in EU notified-body surveillance.
• Medical device software9 guidance entriesQualification, classification, evaluation, or distribution of medical device software.
• Medical device–medicinal product interface4 guidance entriesBorderline and consultation issues involving medicinal products or ancillary medicinal substances.
• Notified bodies34 guidance entriesRequirements and activities of medical-device notified bodies.
• Notified-body audits4 guidance entriesAudit methods and extraordinary audit arrangements for notified bodies.
• Notified-body designation and assessment10 guidance entriesDesignation, notification, preliminary assessment, and reassessment of conformity assessment bodies/notified bodies.
• Notified-body fees1 guidance entryPublication and structure of notified-body standard fees.
• Online platforms and app distribution1 guidance entryMaking medical-device software apps available through online platforms.
• Orphan medical devices1 guidance entryClinical evaluation and regulatory considerations for orphan medical devices.
• Performance evaluation2 guidance entriesPerformance evaluation of in vitro diagnostic devices.
• Performance studies4 guidance entriesPlanning, conduct, reporting, modification, or submission of IVDR performance studies.
• Periodic Safety Update Report (PSUR)1 guidance entryPreparation and content of periodic safety update reports.
• Person responsible for regulatory compliance (PRRC)1 guidance entryQualifications and responsibilities of the PRRC.
• Post-market clinical follow-up (PMCF)2 guidance entriesPMCF plans and evaluation reports.
• Post-market surveillance1 guidance entryPost-market surveillance systems, plans, reports, and activities.
• Post-market surveillance and vigilance9 guidance entriesUmbrella category for post-market surveillance and vigilance.
• Protective equipment and medical face masks3 guidance entriesConformity and market requirements for PPE and medical face masks.
• Quality management systems1 guidance entryIntegration of regulatory requirements into a quality management system.
• Repackaging and relabelling1 guidance entryActivities and certification under MDR/IVDR Article 16.
• Safety reporting2 guidance entriesSafety reporting in clinical investigations or performance studies.
• SARS-CoV-2 diagnostic tests4 guidance entriesQualification, performance, and market guidance for SARS-CoV-2 diagnostic tests.
• Standards and standardisation3 guidance entriesMedical-device standardisation and harmonised standards.
• Sterilisation and ethylene oxide1 guidance entryRegulatory status and use of sterilisation substances/processes including ethylene oxide.
• Summary of safety and clinical/performance information3 guidance entriesSSCP or SSP preparation, publication, and management.
• Technical-documentation sampling1 guidance entrySampling of devices or technical documentation for assessment.
• Unique Device Identification (UDI)15 guidance entriesUDI system, assignment, and integration requirements.
• Vigilance2 guidance entriesIncident reporting, trend reporting, and vigilance concepts.