What are the steps to obtain CE marking for a medical device?

To obtain CE marking for a medical device under EU MDR 2017/745, you must classify your device, establish a quality management system, prepare technical documentation including clinical evaluation, engage a Notified Body (for Class Is, Im, IIa, IIb, and III), and issue a Declaration of Conformity. The process typically takes 12-18 months for Class IIa devices and longer for higher risk classes.

Step 1: Determine the regulatory status of your product

Before beginning the CE marking process, confirm that your product falls within the definition of a medical device under MDR Article 2(1). A medical device is any instrument, apparatus, or software intended for a medical purpose that does not achieve its principal action by pharmacological, immunological, or metabolic means.

If your product qualifies as an in vitro diagnostic device, it falls under IVDR 2017/746 instead.

Step 2: Classify your device

Device classification determines the conformity assessment route and the level of Notified Body involvement. Under MDR Annex VIII, devices are classified into four risk classes:

Classification follows 22 rules in Annex VIII. For software as a medical device (SaMD), Rule 11 applies, with classification depending on the intended purpose and the information provided to clinical decisions.

Step 3: Identify the applicable conformity assessment procedure

MDR Article 52 specifies the conformity assessment procedure for each device class:

• Class I (non-sterile, non-measuring): Self-certification by the manufacturer. No Notified Body required.
• Class Is/Im: Notified Body involvement limited to sterility or measuring aspects.
• Class IIa: Notified Body assesses the quality management system or product verification (Annex IX or Annex XI).
• Class IIb and III: Full Notified Body assessment of technical documentation and quality management system (Annex IX or Annex X + Annex XI).

Step 4: Implement a quality management system

All manufacturers must establish, document, and maintain a quality management system (QMS) as required by MDR Article 10(9). The QMS must cover:

• Regulatory strategy and conformity assessment planning
• Device design and development controls
• Production, purchasing, and supplier management
• Post-market surveillance procedures
• Vigilance and incident reporting (MDR Articles 87-92)

The harmonised standard EN ISO 13485:2016 provides a presumption of conformity for most QMS requirements.

Step 5: Prepare technical documentation

Technical documentation must demonstrate conformity with the relevant General Safety and Performance Requirements (GSPR) in MDR Annex I. The structure follows MDR Annex II and Annex III:

Annex II — Technical documentation:

• Device description and specification
• Design and manufacturing information
• GSPR checklist with references to applied standards
• Benefit-risk analysis and risk management (EN ISO 14971:2019)
• Product verification and validation
• Clinical evaluation report

Annex III — Post-market surveillance documentation:

• Post-market surveillance plan
• Post-market clinical follow-up (PMCF) plan
• Periodic safety update report (PSUR) for Class IIa, IIb, and III

Step 6: Conduct clinical evaluation

Clinical evaluation is mandatory for all device classes under MDR Article 61. The clinical evaluation report must:

• Define the scope and context of the evaluation
• Identify relevant clinical data (literature, clinical investigations, post-market data)
• Appraise and analyse the data
• Demonstrate conformity with relevant GSPR

For Class III implantable devices, clinical investigations are generally required unless justified exceptions under Article 61(4)-(6) apply. MDCG 2020-5 provides guidance on clinical evaluation.

Step 7: Appoint a European Authorized Representative (if needed)

Manufacturers established outside the EU must appoint an Authorized Representative within the EU before placing their device on the market (MDR Article 11). The Authorized Representative acts on behalf of the manufacturer for regulatory interactions.

Step 8: Engage a Notified Body

For all device classes except Class I (non-sterile, non-measuring), submit an application to a Notified Body designated under MDR. Find designated Notified Bodies on the NANDO database.

The Notified Body will:

• Review the technical documentation
• Audit the quality management system
• Conduct unannounced audits (for Class IIa, IIb, III)
• Issue an EU certificate upon successful assessment

Step 9: Draw up the EU Declaration of Conformity

Once assessment is complete, the manufacturer issues the EU Declaration of Conformity per MDR Article 19 and Annex IV. This declaration states that the device meets all applicable requirements of the MDR.

Step 10: Affix the CE mark and register

After drawing up the Declaration of Conformity:

1. Affix CE marking to the device, its packaging, and instructions for use (MDR Article 20)
2. Register in EUDAMED — the European database for medical devices. Registration covers the manufacturer, the Authorized Representative (if applicable), and each device (MDR Articles 29-34)
3. Assign a UDI — Unique Device Identifier per MDR Article 27 and Annex VI

Key takeaways

• CE marking under MDR requires classification (Annex VIII), technical documentation (Annex II/III), clinical evaluation (Article 61), and a QMS (Article 10(9))
• Class I non-sterile/non-measuring devices can self-certify; all others need a Notified Body
• EN ISO 13485:2016 provides presumption of conformity for QMS requirements
• Clinical investigations are generally required for Class III implantables unless exceptions apply
• All devices must be registered in EUDAMED with a UDI before market placement

How RegAid helps

RegAid lets you search the full text of EU MDR 2017/745, all 139 MDCG guidance documents, and harmonised standards — and get cited answers in seconds. Ask "What are the conformity assessment options for a Class IIb device?" and get a structured answer with clickable citations to MDR Article 52, Annex IX, and Annex XI.