Medical Device CE Certification (MDD Directive) Overview

In order to eliminate trade barriers between member states, the EU has gradually established itself as a unified large market to ensure the free flow of people, services, funds and products (such as medical devices). In the field of medical devices, the European Commission has enacted three EU directives to replace the original member's accreditation system, so that the regulations on the placement of such products on the market are coordinated.

These three instructions are:

1. Active Implantable Medical Device Directive (AIMD, 90/335/EEC) for active implantable medical devices such as cardiac pacemakers and implantable insulin pumps. AIMD entered into force on January 1, 1993. The transition deadline is December 31, 1994, and is enforced from January 1, 1995.

2. In Vitro Diagnostic Instrument Directive (IVD), applicable to medical instruments for in vitro diagnostics such as blood cell counters and pregnancy detection devices. The directive is still in the drafting phase and may be formally implemented in late 1998 or early 1999.

3. Medical Devices Directive (93/42/EEC), for a wide range of applications, including almost all medical devices other than active implantable and in vitro diagnostic devices, such as passive medical devices (dressings, disposable products, contact lenses, blood bags, catheters, etc.); and active medical devices such as nuclear magnetic resonance instruments, ultrasound diagnostic and therapeutic devices, infusion pumps, etc.

Scope of certification

Active medical device

a

Ultrasonic lithotripter

Nuclear magnetic resonance NMR

Shadowless lamp

Operating bed, etc.

Passive medical device

syringe

Medical gauze

Medical gloves

Brackets, etc.

Information required for medical equipment to apply for CE certification

A, company profile and European agent name, contact information

B, 1. Product manual sales brochure.

2. Product overview and table of differences in model parameters.

3. Product images (including outer packaging and internal materials as well as photos of various logos).

4. List of raw materials.

5. A copy of the quality related certificate (if any).

6. Use the product's blending standards / or other standards

7. Risk analysis assessment conclusions and preventive measures and potential risk assessment

8. Packaging and identification

a) Packaging material description and medical identification and warning signs

b) label (nameplate)

9. Test report (test report at product registration)

a) Biocompatibility testing

b) Physical properties, chemical tests (material reports or ROSH reports, etc.)

10. Clinical evaluation

a) Product clinical test report and related literature

b) Overview of clinical use and authoritative views

11. Product production process steps (from parts procurement to finished product sales)

Note: Clinical studies (including: physical properties, biochemistry, pharmacology, pharmacokinetics and toxicity studies, efficacy tests, sterilization certification, drug compatibility, etc.)

MDD certification process

MDD certification can be obtained within 1-3 months of complete product information

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