Market Access

MDR | Regulation (EU) 2017/745)

CE Marking Consultancy for Medical Devices – Regulation (EU) 2017/745 (MDR)

At Alpine Quality Consultants, we provide expert CE Marking consultancy services to help medical device manufacturers comply with Regulation (EU) 2017/745 (MDR) and achieve seamless market access in the European Union (EU).

What is CE Marking for Medical Devices?

CE Marking is a mandatory certification that confirms a medical device meets EU safety, performance, and regulatory requirements under MDR (EU 2017/745). It allows free movement of medical devices within the European Economic Area (EEA) and is a prerequisite for selling devices in the EU.

  • Confirms compliance with MDR 2017/745
  • Required for all medical devices (Class I, IIa, IIb, III)
  • Demonstrates product safety, quality, and regulatory conformity
  • Mandatory for market entry in the EU

Understanding the EU MDR Conformity Assessment Routes

The conformity assessment process under EU MDR 745 varies depending on the risk classification of medical devices (Class I, IIa, IIb, III). Our consultants guide you through the appropriate route to compliance.

Self-Certification (Class I Non-Sterile & Non-Measuring Devices)

  • Manufacturers can self-certify by preparing a Technical File and Declaration of Conformity (DoC).
  • No involvement of a Notified Body is required.

Notified Body Assessment (Class I Sterile, Measuring & Higher-Risk Devices)

  • Class I devices with sterile, measuring, or reusable surgical functions require Notified Body involvement.
  • A conformity assessment must be conducted to ensure compliance with MDR requirements.

Full Quality Assurance (Annex IX – Class IIa, IIb, III)

  • The manufacturer’s Quality Management System (QMS) undergoes an audit by a Notified Body.
  • A CE Mark is granted upon successful compliance verification.

Type Examination (Annex X – Class III Devices)

  • Evaluation of the medical device’s design and safety against MDR standards.
  • Required for high-risk devices before CE marking approval.

Product Conformity Verification (Annex XI – High-Risk Class III Devices)

  • Notified Body conducts batch or unit verification of high-risk implantable medical devices.
  • Used for customized or high-risk Class III

Our CE Marking Consultancy Services

Medical Device Classification & Regulatory Strategy

  • Identifying the correct MDR classification (Class I, IIa, IIb, III)
  • Determining the appropriate conformity assessment route

Technical Documentation Preparation & Review

  • Ensuring compliance with Annex II & III of MDR
  • Preparing Device Technical File & Design Dossier
  • Assisting with clinical evaluation reports (CER)

EU Authorized Representative (E.A.R.) Services

  • Acting as your official EU Representative for regulatory compliance
  • Managing EUDAMED registration & post-market surveillance (PMS)

Notified Body Interaction & Certification Support

  • Assisting in selecting a Notified Body (for Class IIa, IIb, III devices)
  • Supporting the conformity assessment & audit process

Risk Management & Post-Market Surveillance (PMS)

  • Implementing ISO 14971:2019 risk management requirements
  • Developing Post-Market Surveillance (PMS) & Vigilance plans

CE Marking Training & Compliance Consulting

  • Providing expert training & workshops on MDR requirements

CE Marking Process Under MDR 2017/745

  1. Device Classification – Determine risk class (Class I, IIa, IIb, III)
  2. Conformity Assessment – Choose the appropriate certification pathway
  3.  Technical Documentation & Clinical Evaluation – Prepare required documents & testing reports
  4. Notified Body Certification (If Required) – Submit for audit & approval
  5. EUDAMED Registration – Register the manufacturer, device, and UDI in EUDAMED
  6. Declaration of Conformity (DoC) & CE Marking – Issue the DoC and affix the CE Mark
  7. Post-Market Surveillance (PMS) & Vigilance – Ensure ongoing compliance & reporting

Key Documentation for EU MDR 745 Compliance

  • Technical File & Design Dossier – Comprehensive documentation of device specifications and performance data.
  • Clinical Evaluation Report (CER) – Evidence-based safety and performance validation.
  • Risk Management File – Documented risk assessments as per ISO 14971.
  • Post-Market Surveillance (PMS) Plan & Reports – Compliance with continuous monitoring and vigilance requirements.
  • Declaration of Conformity (DoC) – Manufacturer’s legal statement confirming MDR compliance.
  • UDI (Unique Device Identification) – Traceability compliance for medical devices.
  • Quality Management System (ISO 13485 Certification) – Ensuring QMS alignment with MDR.

Who Needs CE Marking Under MDR?

Contract Manufacturers & Suppliers

Medical Device Manufacturers (EU & Non-EU)

Medical Device & IVD Manufacturers

Non-EU Manufacturers (Must appoint an EU Authorized Representative)

Distributors & Importers

Distributors & Importers (Must verify device compliance)

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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