MDR
EU MDR 2017/745: qualify and classify devices, plan conformity assessment, and maintain clinical, technical and post-market evidence.
This MDR hub explains how Regulation (EU) 2017/745 applies to a medical device, accessory, medical-device software or Annex XVI product, then connects that scope decision to classification, market access and lifecycle evidence.
Start with the manufacturer's and EU supply-chain role. Then justify the class, choose the Article 52 conformity route, and keep quality, technical, clinical and post-market records aligned for the device's full lifecycle.
The MDR qualification question turns on what the manufacturer intends the product to do for human beings. Software, accessories and Annex XVI products need the same disciplined scope record before classification or CE planning.
Record the applicable rule, invasiveness, duration of use, active or implantable status, substance or nanomaterial features, software decision impact, and any rule that drives a higher class.
Keep Annex II and III technical documentation, risk management, GSPR mapping, clinical evaluation report, PMCF plan or non-applicability justification, PMS plan, vigilance procedure, data and actor/device records aligned with the released device.
Confirm the manufacturer's , accessory or software status, Annex XVI coverage, exclusions and borderline interfaces before applying a classification rule.
Separate manufacturer, authorised representative, importer and distributor duties; apply , including Rule 11 where relevant; then map the class to the Article 52 route and notified-body involvement.
Tie QMS and risk management controls, technical documentation, clinical evaluation and PMCF, PMS and vigilance, and data, corrective action and any conditional legacy-transition claim to one controlled device history.
Track MDR application, Article 120 legacy-device conditions and the applicable 31 December 2027 or 31 December 2028 transition end date, application and agreement evidence, technical documentation updates, clinical evaluation and PMCF outputs, PMS/vigilance records, assignment, applicable mandatory actor and device registration, certificate status, and market-surveillance correspondence for each device family.
Start with the Summary of Safety and Clinical Performance (), the public safety and clinical evidence summary required for specified devices under the EU Medical Device Regulation (MDR). Use the guide library below for qualification, classification, conformity assessment, clinical evidence, and lifecycle work.
requires an for implantable and devices, except custom-made and investigational devices. For example, a class IIb dental implant needs one because it is implantable, while a non-implantable class IIb imaging system does not. Follow Medical Device Coordination Group () guidance for the content, notified-body validation, translations, and publication process.
New to the MDR? Start by documenting , product qualification and economic-operator role. If scope is settled, jump to classification, conformity assessment, technical or clinical evidence, traceability, transition, post-market controls, enforcement or a focused comparison.
Decide whether the product is a medical device, accessory, medical-device software, Annex XVI product or an interface with another regime before classification begins.
Apply to the documented device facts, resolve software and special-rule questions, select the Article 52 route and confirm the 's designation scope where third-party assessment is required.
Turn manufacturer and supply-chain duties into owned controls, a traceable Annex II and III file, GSPR and risk evidence, supplier records and release gates that reopen when the device changes.
Connect the clinical evaluation plan and report to GSPRs, benefit-risk, equivalence limits, clinical investigations, PMCF, PMS signals and notified-body review.
Control actor and device data separately from conditional Article 120 transition claims, and distinguish fixed legal dates from recurring internal review events.
Route complaints and signals through PMS, PMCF, PSUR or PMS reporting, vigilance clocks, FSCA and CAPA decisions, technical-file updates and national enforcement follow-up.
Keep MDR qualification and evidence distinct from adjacent regimes, or go directly to the FAQ for a specific question about software, accessories, clinical evidence, , or transition.
"common specifications for the groups of products"
"EUDAMED is composed of six modules"
"assess the conformity of certain products"
"manufacturers submit in EUDAMED the UDI/Device information"
"Questions and Answers on the Unique Device Identification system"
"demonstration of equivalence for Annex XVI products"
"rules for the placing on the market"
"extend the validity of certificates"
Next steps
This hub helps route MDR work by device family, , risk class, economic-operator role, status, clinical evidence route and EU market path. Build a controlled device file that stays current throughout the lifecycle.
Turn MDR scope, classification, technical documentation, clinical evaluation, PMS, vigilance, and records into owned tasks and review checkpoints.
Answer MDR scope, classification, conformity assessment, , clinical evidence and legacy-transition questions with cited outputs from official sources.
Align MDR application, Article 120 transition checks, certification work, module readiness and lifecycle evidence across regulatory, quality and clinical teams.
Review your device scope, classification rationale, path, technical file, clinical evidence model, PMS/vigilance process and / setup.