EU MDR/IVDR CE Marking & EU Authorized Representative

EU CE Marking and MDR / IVDR Compliance Guide for Medical Devices: This page covers the regulatory authorities, device classification, registration process, local representative requirements and FAQs for medical devices in the EU. Medical devices in the EU are regulated by the competent authorities of the Member States and by Notified Bodies, and EVERBIZ can support you through the entire process from classification to certification.

1. What Are CE Certification and the CE Mark?

CE stands for the French Conformité Européenne (European Conformity). The CE mark indicates the manufacturer’s commitment that the product meets all applicable EU health, safety, performance and environmental requirements, and that it takes legal responsibility for this.

To sell a medical device or in vitro diagnostic device (IVD) in the European Union (EU), the product must bear the CE mark. The CE mark is also the passport to the European Economic Area (EEA) – the 27 EU Member States plus Iceland, Liechtenstein and Norway – and some non-EU countries such as Switzerland and Turkey also recognize it. The manufacturer bears ultimate responsibility for compliance, and this responsibility cannot be transferred even if some or all production is outsourced to third parties.

2. Core Obligations under the MDR

The legal basis for CE marking of medical devices is the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745), fully applicable since 26 May 2021, which replaced the Medical Device Directive (MDD, 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD, 90/385/EEC).

The manufacturer’s main obligations include:

Obligation	Description
General Safety and Performance Requirements (GSPR)	Demonstrate that the device meets all applicable requirements of MDR Annex I
Technical documentation	Prepared and continuously maintained in accordance with MDR Annexes II and III
Clinical evaluation	CER prepared in accordance with MDR Annex XIV and MEDDEV 2.7/1 rev.4
Quality management system (QMS)	Usually established on the basis of ISO 13485
Post-market surveillance (PMS)	Ongoing activities including PSUR and PMCF
EUDAMED registration	Data on economic operators, devices, UDI, etc.
Notified Body (NB)	Required for all devices except Class I (non-sterile, without measuring function, not reusable surgical instruments)
EU Authorized Representative (EC REP)	Mandatory for manufacturers located outside the EU
Declaration of Conformity (DoC)	Self-declaration that the product complies with the MDR

3. Basic CE Certification Process

Determine the product definition – confirm whether the product is a medical device under MDR Article 2.
Determine the class – classify as Class I, IIa, IIb or III under MDR Annex VIII.
Establish a QMS – in most cases based on ISO 13485.
Prepare the technical documentation – including design, risk management, biological evaluation and clinical modules.
Complete the clinical evaluation – gather evidence through literature, equivalence or clinical investigations.
Appoint an EC REP (for manufacturers outside the EU).
Notified Body assessment – review of the QMS and technical documentation (except self-declared Class I devices).
EUDAMED registration – assign UDIs and register the device and economic operators.
Sign the DoC and affix the CE mark – the product can then be placed on the EU market.

4. IVDR: A Separate Regulation for In Vitro Diagnostic Devices

In vitro diagnostic devices fall under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746), applicable since 26 May 2022, which replaced the IVD Directive (IVDD, 98/79/EC). The IVDR has a framework similar to the MDR but with several key differences:

1. Different risk classification rules: The IVDR uses a rule-based classification system with four classes:

Class A – low risk (e.g. reagent-grade chemicals, general laboratory containers)
Class B – low-to-moderate risk (e.g. pregnancy self-tests, cholesterol tests)
Class C – moderate-to-high risk (e.g. tumor markers, staging diagnosis of infectious diseases)
Class D – high risk (e.g. HIV, HBV, HCV blood screening)

2. Much wider Notified Body involvement: Under the IVDD only about 8% of IVDs required Notified Body involvement; under the IVDR this rises to about 80% (all Class B, C and D devices and sterile Class A devices require NB review).

3. Stricter performance evaluation requirements: IVDR Annex XIII requires a three-part evaluation of scientific validity, analytical performance and clinical performance, documented in a Performance Evaluation Report (PER).

4. EU reference laboratories for high-risk products: Batches of Class D products must be verified by an EU Reference Laboratory (EURL).

5. Key Transition Periods and Latest Updates

MDR transition periods (under Regulation (EU) 2023/607)

Compliant devices meeting the conditions may remain on the market for longer, with deadlines depending on the risk class:

Device class	Latest deadline
Class III and Class IIb implantable (excluding sutures, dental fillings, etc.)	31 December 2027
Other Class IIb, Class IIa, Class I (sterile or measuring)	31 December 2028
Class III custom-made implantable devices	26 May 2026

Conditions for the extension:

Application to an MDR Notified Body lodged before 26 May 2026, and a written agreement signed with the Notified Body before 26 September 2024
A QMS compliant with MDR Article 10(9) is in place
No significant changes in the design or intended purpose of the device

IVDR transition periods (under Regulation (EU) 2024/1860)

Regulation (EU) 2024/1860, in force since 9 July 2024, further extended the IVDR transition periods:

IVD class	Latest deadline
Class D	31 December 2027
Class C	31 December 2028
Class B, sterile Class A	31 December 2029

Other important changes (Regulation (EU) 2024/1860)

Module-by-module mandatory use of EUDAMED – instead of waiting for all six modules to be fully functional, use becomes mandatory module by module, with the first modules expected to become mandatory from January 2026.
Obligation to notify supply interruptions – since 10 January 2025, manufacturers planning to interrupt or discontinue the supply of certain medical devices or IVDs must notify the competent authority in advance and, where necessary, their customers.
“Sell-off” deadline removed – devices already lawfully placed on the market can continue to be made available without a common cut-off date.

6. EVERBIZ Support Services

Our European regulatory team can support you with:

Regulatory strategy and classification – MDR / IVDR applicability analysis and transition pathway planning
Technical documentation – structured according to MDR Annexes II and III or IVDR Annexes II and III
Clinical / performance evaluation – CER and PER writing and literature searches
Quality management system – ISO 13485 system setup and internal audits
Notified Body liaison – selection, application and responses to findings
EU Authorized Representative (EC REP) – with compliance offices in several European locations, we can act as your EC REP
EUDAMED registration and UDI assignment
Post-market compliance – ongoing PMS, PMCF and PSUR support

How EVERBIZ Can Help

EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. Our Munich-based EVERBIZ GmbH can act as your EU Authorized Representative. For the EU market, we offer:

Product classification and registration pathway planning
Preparation and review of MDR/IVDR technical documentation, clinical evaluation reports and declarations of conformity
Local authorized representative / registration holder arrangements
Submission, responses to deficiency letters and progress tracking
Post-market compliance maintenance (changes, renewals, adverse event reporting)

Contact us for an EU medical device registration plan and quote, or see our registration services for other countries and regions.

EU Medical Device Registration FAQs

What is the legal basis for EU CE marking?

Medical devices are governed by the Medical Device Regulation (MDR, Regulation (EU) 2017/745), and in vitro diagnostic devices by the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746).

Must non-EU manufacturers appoint an EU Authorized Representative?

Yes. Under Article 11 of the MDR/IVDR, manufacturers located outside the EU must appoint an authorized representative established in the EU by means of a written mandate, and the authorized representative is jointly and severally liable for compliance.

Do all medical devices require Notified Body assessment?

No. Class I devices (other than sterile, measuring or reusable surgical instruments) can be self-declared by the manufacturer; Class Is/Im/Ir devices and Class IIa, IIb and III devices require Notified Body (NB) assessment.

Until when has the MDR transition period been extended?

Under Regulation (EU) 2023/607, provided the conditions are met, Class III and Class IIb implantable devices may benefit until 31 December 2027, and other Class IIb, Class IIa and Class I devices requiring a Notified Body until 31 December 2028.

EU Medical Device CE Marking (MDR/IVDR)

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