MDR Medical Device Certification Service

In the medical device sector, the European Commission has issued three unified EU directives to replace independent national approval systems and harmonize market access rules across member states:

01 Medical Device Directive (MDD)

93/42/EEC, covering most medical devices except active implantable devices and in vitro diagnostic devices.
02 In Vitro Diagnostic Directive (IVDD)

98/79/EC, applicable to in vitro diagnostic devices such as blood cell counters and pregnancy test kits.
03 Active Implantable Medical Device Directive (AIMDD)

90/385/EEC, governing active implantable devices including pacemakers and implantable insulin pumps.

MDR Overview

The new regulation MDR (EU) 2017/745 became fully mandatory in May 2020. MDR is a formal EU regulation upgraded from the former MDD directive, bringing stricter supervision over certification procedures and compliance results within all EU member states. Key updates are as follows:

01 Strengthened Manufacturer Obligations

a. Manufacturers must appoint a qualified person responsible for regulatory compliance (mandatory under MDR, not required by MDD);

b. Establish and continuously update technical documentation for inspection by competent authorities;

c. Undertake unannounced audits by notified bodies for Class II devices to maintain technical files and quality systems;

d. More stringent requirements for traders applying for CE certification;
02 Expanded Clauses & Strict Review

a. Classification rules increased from 18 (MDD) to 22;

b. General safety and performance checklist items expanded from 13 to 23;

c. Technical documents divided into device technical files and post-market surveillance files (MDD only required device technical files);

d. Mandatory Version 4 clinical evaluation reports with more rigorous assessment criteria compared to Version 3;
03 Extended Regulatory Scope

a. Unlike MDD focusing only on medical-purpose products, MDR covers non-medical devices such as cosmetic contact lenses and aesthetic devices;

b. Reusable surgical instruments, previously classified as Class I without notified body involvement under MDD, require conformity assessment by notified bodies under MDR;
04 Higher Transparency & Traceability

a. Introduction of Unique Device Identification (UDI) to enhance full-lifecycle traceability;

b. Mandatory registration in the European Database on Medical Devices (EUDAMED);

c. Compulsory Post-Market Surveillance (PMS) system;

d. Regular unannounced audits conducted by notified bodies.

What is a Clinical Evaluation Report?

01
Clinical trials collect human trial data to verify device safety and performance.
02
Clinical evaluation proves product safety and effectiveness through device comparison, data analysis and literature review.
03
The clinical evaluation report is a core and mandatory component of CE technical documentation for medical device certification.
04
The current applicable version is Edition 4, compiled in accordance with MedDev 2.7.1 clinical evaluation guidelines.

Differences Between MDR EU Authorized Representative and MDD EU Authorized Representative

The EU Authorised Representative (AR) is a natural or legal person established within the EU, formally authorised by non-EU manufacturers to perform regulatory obligations on their behalf. Acting as the official liaison with European authorities, the AR must have a physical local presence, retain technical documents for competent authority inspection, and display its name and address on product labels and instructions. In case of safety incidents, the AR coordinates regulatory reporting and emergency handling.

Compared with MDD requirements, MDR imposes stricter obligations and joint legal liabilities on EU authorised representatives for defective devices. The AR must employ a permanently available compliance officer with professional expertise in EU medical device regulations, meeting one of the following qualification requirements:

(a) A university degree in law, medicine, pharmacy, engineering or other relevant scientific disciplines, plus at least one year of working experience in medical device regulatory affairs or quality management systems;

(b) A minimum of four years of professional experience in medical device regulatory affairs or quality management systems.

Medical Device Classification under MDR

The MDD directive divides medical devices into six risk classes for conformity assessment:

Class	Design Phase	Production Phase
Class I	Self-declaration	Self-declaration
Class I (Measuring Function)	Self-declaration	Notified Body Audit
Class I (Sterile)	Self-declaration	Notified Body Audit
Class IIa	Self-declaration	Notified Body Audit
Class IIb	Notified Body Audit	Notified Body Audit
Class III	Notified Body Audit	Notified Body Audit

Technical Documents Required for Medical Device Certification

Conformity assessment includes technical document review against essential requirements and quality system audit complying with EN 46001 or EN/ISO 13485. Full technical documentation for medical device CE certification covers:

- Manufacturer / EU authorised representative name and address;
- Product description and model specifications;
- EC Declaration of Conformity;
- Risk assessment report;
- General safety and performance checklist;
- Harmonized standards and applicable normative documents;
- Post-market feedback and complaint analysis;
- User manual, labeling and packaging information;
- Authorised representative appointment documents;
- Circuit diagrams and structural drawings (if applicable);
- Design calculation documents, test reports and verification data;
- Production process control records;
- Sterilization and special process documents (if applicable);
- Packaging materials and sterilization validation for sterile devices;
- Quality management system documents including quality manual;