EU market entrants
Manufacturers planning first CE marking under EU MDR 2017/745 with structured technical documentation.
- MDR
- Class I-III
- GSPR
EU · CE Marking
CE Marking Consultant for Medical Devices under EU MDR 2017/745
Build EU MDR and IVDR technical documentation, GSPR evidence, clinical or performance evaluation files, and notified body readiness for CE marking.
- 25+Years Experience
- 500+Companies
- EU MDR Support
- GSPR · CER
CE marking pathway
- 1Confirm MDR vs IVDR scope
- 2Classify device under EU rules
- 3Build technical documentation and GSPR evidence
- 4Plan conformity route and notified body readiness
EU MDR 2017/745EU IVDR 2017/746GSPRCERNB
Which regulation applies?
- General medical devicesEU MDR 2017/745
- IVD productsEU IVDR 2017/746
- Class I (MDR)Self-declaration where applicable
- Class IIa and aboveNotified body conformity route
- UK market accessUKCA planning alongside CE
Who needs this
Who needs CE marking support
NQSC supports EU market entrants, IVD manufacturers, legacy transitions, Indian exporters, CMOs, and teams planning UKCA alongside CE.
IVD manufacturers
IVD teams preparing IVDR classification, performance evaluation, and technical documentation for CE marking.
- IVDR
- IVD
- Performance
Legacy MDD transitions
Devices migrating from MDD or AIMDD to MDR requirements with gap mapping and updated technical files.
- Transition
- MDR
- Gap map
Indian manufacturers exporting to EU
India-based sites aligning QMS records, technical files, and notified body readiness for EU market access.
- Export
- ISO 13485
- EU
Contract manufacturers and OEM partners
CMOs and OEMs coordinating design responsibility, technical documentation, and conformity evidence.
- CMO
- OEM
- Technical file
UK market planners
Teams assessing UKCA requirements alongside CE for UK market access without confusing UKCA with CE.
- UKCA
- CE
- UK market
Compare routes
EU MDR 2017/745 vs EU IVDR 2017/746
Understand which regulation applies and how technical documentation and evaluation requirements differ before building your CE marking dossier.
EU MDR (Medical Devices)
Best for: general medical devices under EU MDR 2017/745.
- Technical documentation, GSPR, and ISO 14971 risk management
- Clinical evaluation and PMCF where applicable
- Notified body involvement commonly required for Class IIa and above
Relevant forms
- MDR
- GSPR
- CER
- NB
EU IVDR (IVD)
Best for: in vitro diagnostic devices under EU IVDR 2017/746.
- IVDR classification and performance evaluation files
- PMPF and IVDR technical documentation requirements
- Conformity route depends on IVD class and device risk
Relevant forms
- IVDR
- Performance
- PMPF
- NB
Documentation
Documentation typically reviewed for CE marking readiness
Grouped for gap review before notified body submission or self-declaration planning.
Technical Documentation
- Device description and intended purpose
- Classification rationale under MDR or IVDR
- Labels, IFU, and packaging artwork
- Design and manufacturing overview
GSPR & Standards
- GSPR checklist and evidence map
- Harmonized standards list
- Essential requirements cross-reference
- Verification and validation summaries
Risk Management
- ISO 14971 risk management file
- Benefit-risk analysis
- Residual risk and control measures
- Risk linkage to design and PMS
Clinical & Performance
- Clinical evaluation plan and report (MDR)
- Performance evaluation file (IVDR), where applicable
- Literature review and evidence tables
- PMCF or PMPF planning where applicable
QMS & Notified Body
- ISO 13485 certificate or QMS status
- Notified body selection criteria
- Declaration of Conformity draft
- EUDAMED and economic operator planning
Post-Market Readiness
- Post-market surveillance plan
- Vigilance and complaint procedures
- PSUR or SSCP where applicable
- Documentation update and change control
Note: Final document scope is confirmed after reviewing device class, regulation (MDR or IVDR), conformity route, and target markets.
Process
From classification to CE marking readiness
A structured process for regulation scope, conformity route planning, technical documentation, clinical or performance evaluation, and post-market planning.
Regulation and classification scope
Confirm whether EU MDR 2017/745 or EU IVDR 2017/746 applies and classify the device under applicable rules.
Conformity route planning
Identify self-declaration, notified body involvement, and annex route based on class and device risk.
Technical documentation and GSPR
Build technical documentation, GSPR evidence maps, standards lists, and verification or validation summaries.
Clinical or performance evaluation
Prepare clinical evaluation or performance evaluation files, literature reviews, and PMCF or PMPF where applicable.
QMS and notified body coordination
Align ISO 13485 status, notified body selection, submission readiness, and Declaration of Conformity planning.
Post-market planning
Plan PMS, vigilance, EUDAMED registration, and ongoing documentation updates after market placement.
How NQSC helps
Support across technical documentation and notified body readiness
NQSC supports classification, GSPR mapping, risk and clinical files, notified body preparation, and post-market documentation for EU MDR and IVDR pathways.
Classification and route guidance
Confirm MDR vs IVDR scope, device class, and conformity route before technical documentation build-out.
Technical file and GSPR support
Structure technical documentation, GSPR checklists, standards evidence, and labeling or IFU alignment.
Risk management alignment
Support ISO 14971 risk files, benefit-risk summaries, and linkage to design and post-market processes.
Clinical and performance evaluation
Guide CER planning under MDR or performance evaluation under IVDR, including literature and PMCF or PMPF.
Notified body audit readiness
Prepare submission packs, mock reviews, and response support for notified body questions and findings.
Post-market and vigilance support
Support PMS planning, vigilance processes, periodic updates, and documentation maintenance after CE marking.
Avoid delays
Avoidable issues that delay CE marking readiness
Issues NQSC often sees during EU MDR and IVDR technical documentation and conformity reviews.
Wrong MDR classification
Rule misapplication affects conformity route, notified body involvement, and clinical evidence expectations.
Incomplete GSPR mapping
Missing links between harmonized standards, verification evidence, and General Safety and Performance Requirements.
Weak clinical evaluation
CER or performance evaluation gaps for higher-risk, implantable, or novel devices before notified body review.
UKCA confusion
UKCA is separate from CE for UK market access. UKCE is not an official designation.
Weak PMS or PMCF planning
Post-market surveillance, PMCF, or PMPF plans not aligned with device class, risk, and regulation.
EUDAMED or UDI readiness gaps
Registration, UDI, or economic operator details not prepared alongside technical documentation.
Client trust
Client feedback on NQSC CE and regulatory support
Feedback from teams supported across CE marking, EU MDR and IVDR documentation, ISO certification, and compliance coordination.
ISO · CE · CDSCO
“Excellent support throughout certification activities, including ISO, CE marking and CDSCO submissions.”
CDSCO · Manufacturing
“Fast and accurate service.”
Regulatory Support
“We are fully satisfied with the services provided by NQSC.”
Selected clients supported by NQSC
FAQ
Questions before you apply
Short answers on MDR, IVDR, documentation, timelines, and how NQSC supports your CE marking pathway.
EU MDR 2017/745 is the European regulation governing medical devices. NQSC supports technical documentation, GSPR mapping, and clinical evaluation aligned to MDR requirements.
EU MDR 2017/745 applies to general medical devices. EU IVDR 2017/746 applies to in vitro diagnostic devices. Documentation, classification, and evaluation routes differ between the two regulations.
No. Conformity assessment and CE certification are performed by notified bodies. NQSC supports documentation, gap analysis, and audit readiness.
Common documents include technical documentation, GSPR evidence, ISO 14971 risk file, clinical evaluation or performance evaluation, QMS status, labeling, and post-market plans where applicable.
Timelines depend on device class, clinical or performance evidence, documentation maturity, and notified body scheduling. NQSC helps reduce avoidable delays through structured documentation support.
UKCA applies for UK market access where relevant and is separate from CE. NQSC can advise alongside CE planning. UKCE is not an official designation.
Planning CE marking under EU MDR or IVDR?
Share device class, regulation scope, target markets, and documentation readiness. NQSC will help outline technical file and evaluation scope.