EU MDR Certification Process Explained: CE Marking Requirements for Medical Devices

Understanding Your Medical Device Classification

Before initiating the certification process, manufacturers must correctly classify their medical devices according to the rules defined in MDR Annex VIII. Devices are categorized into four risk classes:

1. Class I
2. Class IIa
3. Class IIb
4. Class III

For Class I devices (excluding sterile, measuring, or reusable surgical instruments), manufacturers may generally self-declare conformity.

However, involvement of a Notified Body is required for:

1. Class Is (sterile)
2. Class Im (measuring)
3. Class Ir (reusable surgical instruments)
4. Class IIa, IIb, and Class III

It is important to note that for Class Is, Im, and Ir devices, the Notified Body’s assessment is limited to specific aspects (e.g., sterility, measurement function, or reusability), rather than the entire device.

The classification directly determines the applicable conformity assessment route (e.g., Annex IX, X, or XI) and the level of scrutiny.

MDR Transitional Period – Key Update

According to Regulation (EU) 2023/607, the MDR transitional period has been extended:

1. High-risk devices (Class III and certain Class IIb implantables): until December 31, 2027
2. Medium and lower-risk devices (Class IIa and certain Class IIb): until December 31, 2028

This extension applies only if:

1. The MDD certificate remains valid
2. No significant design changes are made
3. The manufacturer has initiated MDR certification procedures

Therefore, May 26, 2024 is no longer the universal final deadline, but rather a key milestone within the transitional framework.

MDR Certification Process (Typical Notified Body Workflow)

The MDR certification journey typically involves the following structured steps when working with a Notified Body (e.g., DQS):

• Initial Information Exchange and Project Preparation

Manufacturers provide key information such as intended use, device classification, technical scope, and proposed conformity assessment route. This enables the Notified Body to evaluate feasibility and issue a quotation.

• Submission of Formal Application

The conformity assessment procedure officially begins once the Notified Body accepts a complete application.

•  Application Review and Acceptance

The Notified Body reviews the submitted data and may request clarifications or additional documentation. Upon successful review, the application is formally accepted.

• Technical Documentation Review and QMS Assessment (Core Phase)

This phase consists of two parallel activities:

Technical Documentation Assessment

Evaluation against MDR Annex I (General Safety and Performance Requirements – GSPR), including:

1. Clinical Evaluation
2. Risk Management (ISO 14971)
3. PMS / PMCF plans
4. Technical Documentation

High-risk devices may be subject to 100% documentation review.

Quality Management System (QMS) Audit

Manufacturers must implement a QMS compliant with MDR requirements.

In practice, most manufacturers establish their QMS based on ISO 13485:2016, which serves as a widely accepted foundation (note: ISO 13485 certification alone does not equal MDR compliance).

The audit typically includes:

1. Stage 1: Documentation review
2. Stage 2: On-site audit

• Independent Certification Decision

Assessment results are submitted to an independent decision-making body within the Notified Body to ensure objectivity and regulatory compliance.

• Certificate Issuance and Post-Market Surveillance

Upon successful assessment, the Notified Body issues an MDR CE certificate, typically valid for up to five years.

However, certification is not the end of the process. Manufacturers must maintain compliance through:

1. Annual surveillance audits
2. Unannounced audits
3. Ongoing technical documentation review

Post-Market Obligations and EUDAMED Update

Manufacturers are required to fulfill ongoing obligations, including:

1. Establishing a Post-Market Surveillance (PMS) system
2. Conducting Post-Market Clinical Follow-up (PMCF)
3. Assigning Unique Device Identification (UDI)

Regarding EUDAMED:

1. The system is being implemented in a phased approach
2. Core modules are expected to become mandatory starting from 2026 onwards
3. Manufacturers must comply with registration and data submission requirements according to the official rollout timeline

Choosing the Right Notified Body

Under MDR, the Notified Body plays a critical role not only in conformity assessment but also as a strategic compliance partner.

For example, DQS Medizinprodukte GmbH is an EU-designated Notified Body (NB 0297) providing MDR certification services, supported by extensive technical expertise and global auditing resources.

Selecting an experienced and competent Notified Body can help:

1. Reduce regulatory delays
2. Improve documentation quality
3. Accelerate time-to-market

Conclusion

The MDR certification process involves multiple layers of regulatory and technical requirements. From device classification and clinical evidence to QMS implementation and post-market obligations, each step requires careful planning and execution.

Early preparation and collaboration with a qualified Notified Body are essential for successfully entering the European market.

Associated Services by DQS HK

• MDSAP Certification
• ISO 13485 Certification
• MDR Certification
• ISO 13485 Auditor Training

Frequently Asked Questions (FAQ)

What is the main difference between MDR and MDD?

MDR introduces stricter requirements compared to MDD, including:

1. Stronger clinical evidence requirements
2. Enhanced post-market surveillance (PMS/PMCF)
3. Introduction of UDI and EUDAMED
4. Clear responsibilities for economic operators

Overall, MDR emphasizes lifecycle-based product safety and traceability.

Can medical devices still be marketed in the EU without MDR certification?

In certain cases, yes.

Under Regulation (EU) 2023/607, devices with valid MDD certificates may continue to be placed on the market during the transition period, provided that:

1. No significant design changes are made
2. MDR certification has been initiated

Deadlines:

1. High-risk devices: until end of 2027
2. Medium/low-risk devices: until end of 2028

New devices must comply with MDR immediately.

How long does MDR certification take?

Typically, MDR certification takes 12 to 24 months or longer, depending on:

1. Device classification
2. Completeness of technical documentation
3. Availability of the Notified Body
4. Need for additional data or corrections

Early preparation is strongly recommended.

Is ISO 13485 certification equivalent to MDR compliance?

No.

ISO 13485 is a quality management standard aligned with MDR requirements, but:

1. It does not replace MDR compliance
2. Additional regulatory requirements must still be fulfilled

Do all medical devices require a Notified Body?

No.

1. Standard Class I devices can be self-certified
2. Higher-risk devices and certain Class I variants require Notified Body involvement

Is EUDAMED already mandatory?

Not fully.

EUDAMED is being rolled out in phases, with key modules expected to become mandatory starting from 2026.

Manufacturers must prepare accordingly and comply as modules become active.

What are PMS and PMCF, and are they mandatory?

Yes, both are mandatory under MDR.

1. PMS (Post-Market Surveillance): continuous monitoring of device safety and performance
2. PMCF (Post-Market Clinical Follow-up): ongoing clinical data collection

All devices require PMS; PMCF requirements depend on risk and available clinical data.