CE MDD

General

The Medical Device Directive is intended to harmonize the laws related to medical devices within the European Union. In order to legally place medical device(s) on the European market, manufacturer(s) should comply with the requirements of the MD Directive. Product(s) and the quality system of an applicant must be assessed and the manufacturer must affix the CE marking before placing the product(s) on the market. 

 

Applicable Products

The Medical Device Directive is applicable to the devices conforming to the definition of "medical device". Medical device? means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and of which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

 

Conformity Assessment Procedure 

 

Classification

Annex IX of Medical Device Directive (93/42/EEC) provides 18 rules to classify medical devices. According to these Rules, medical devices are classified by their intended purposes.

· Rule 1 ~ 4: non invasive devices
· Rule 5 ~ 8: invasive devices
· Rule 9 ~ 12: active devices
· Rule 13 ~ 18: special rules

Risk value of medical devices to patient or user is identified and classified in accordance with those 18 rules.

 

Depending on the identified risk value, the conformity assessment process is decided.

The Higher the risk value is, the stricter the conformity assessment requirements are.

With the above 18 rules, medical devices are classified into class I, I-measuring, I- sterile, IIa, IIb and III. 

 

 

1. Class I medical devices follows assessment procedure Annex VII.

 

2. Procedure of Class I (with measuring function)

· Manufacturer's possible choices:

· Technical documentation according to Sec. 3 of Annex VII and verification of the conformity with metrological requirements on each piece or on a statistically selected sample according to Annex IV

· Technical documentation according to Sec. 3 of Annex VII and assessment of production quality system according to Annex V related to metrological requirements

· Technical documentation according to Sec. 3 of Annex VII and quality assessment of MD according to Annex VI related to metrological requirements

 

3. Procedure of Class I (with sterile)

· Manufacturer possible choices:

· Technical documentation according to Sec. 3 Annex VII and assessment of production quality system according to Annex V related to sterile conditions

 

4. Procedure of Class IIa medical devices

· Manufacturer's possible choices:

· Technical documentation according to Sec. 3 of Annex VII and verification of the conformity with the technical documentation on each piece or on a statistically selected sample according to Sec. 8 of Annex IV

· Technical documentation according to Sec. 3 of Annex VII and assessment of production quality system according to Sec. 6 of Annex V (by an audit at the manufacturer's sites)

· Technical documentation according to Sec. 3 of Annex VII and assessment of medical device quality according to Sec. 6 of Annex VI (by an audit at the manufacturer's sites)

· Technical documentation according to Sec. 3 of Annex VII and assessment of full quality system by an audit at the manufacturer's sites according to Annex II (except design examination according to Sec. 4)

 

5. Procedure of Class IIb medical devices

· Manufacturer's possible choices:

· Technical documentation according to Section 3 of Annex III, examination of type and verification of conformity of each piece manufactured; the verification is done according to Section 5 or on a statistically (randomly) selected sample according to Section 6 of Annex IV

· Technical documentation according to Section 3 of Annex III, examination of type and assessment of production quality system according to Annex V (by an audit of the manufacturer's sites)

· Technical documentation according to Section 3 of Annex III, examination of type and assessment of medical device quality according to Section 6 of Annex VI (by an audit at the manufacturer's sites)

· Technical documentation according to Section 3.2 of Annex II and assessment of full quality system by an audit at the manufacturer's sites according to Annex II (except design examination according to Section 4)

 

6. Procedure of Class III medical devices

· Manufacturer's possible choices:

· Technical documentation according to Section 3.2 of Annex II, description of the design according to Section 4.2 and assessment of full quality system according to Annex II (by an audit at the manufacturer's sites)

· Technical documentation according to Section 3 of Annex III, examination of type and verification of conformity of each piece produced; the verification is done according to Section 5 or on a statistically (randomly) selected sample according to Section 6 of Annex IV

· Technical documentation according to Section 3 of Annex III and Section 3.2 of Annex V, examination of type and assessment of production quality system (by an audit of the manufacturer's sites)

 

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