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Overview
 
· Generally
· Conformity Assessment Procedure According to the MD Directive
· Risk-Analysis for Medical Devices According to EN 1441
· Classification of a Medical Device
 
Generally

The Medical Device Directive (MDD) gives the essential requirements that are applicable for instruments, apparatus, appliances, materials or other articles to be used for human beings for the purpose of:
·  diagnosis, prevention, monitoring, treatment or alleviation of disease;
·  diagnosis, monitoring, treatment or alleviation of or compensation for an injury or handicap;
·  investigation, replacement or modification of the anatomy or of a physiological process;
·  contraception;
and which do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means. However, they may be assisted in their function by such means.

All products within the above scope are analyzed and classified according to risk. To gain access to the European market they must meet the requirements of the MDD and manufacturers have to follow the specified conformity assessment procedure. Compliance of products with the MDD has to be indicated by CE-marking. After a transition period of 5 years the MDD became mandatory on June 14, 1998.

Medical products not within the scope of the MDD may be covered by other medical directives as there are:
AIMD Active Implantable Medical device Directive (mandatory since 01.01.1995)
IVD In-Vitro-Diagnostic-Device Directive (start of the transition period: 01.01.1999)
For most medical products, as specified in the MDD, a Notified Body has to be involved during the conformity assessment procedure. Notified Bodies do have to meet the requirements of Annex 11 of the MDD and must be notified by the European Commission.
TÜV Rheinland Product Safety GmbH is accredited, fulfills the requirements of Annex 11 of the MDD and is notified by the European Commission with registration No. 0197.

 
Conformity Assessment Procedure According to the MD Directive
The essential requirements are categorized into
a) general requirements and
b) requirements regarding design and construction. Below you will find an excerpt from the Medical Device Directive.
 
General requirements:
1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.
2. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
·  eliminate or reduce risks as far as possible (inherently safe design and construction).
·  where appropriate take adequate protection measures including alarms if necessary, in relation to risks that can not be eliminated.
·  inform users of the residual risks due to any shortcomings of the protection measures adopted.
3. he devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer.
4. The characteristics and performances referred to in sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical condition and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.
5. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.
6. Any undesirable side effects must constitute an acceptable risk when weighed against the performances intended.
  Requirements regarding design and construction
7. Chemical, physical and biological properties
8. Infection and microbial contamination
9. Construction and environmental properties
10. Devices with a measuring function
11. Protection against radiation
12. Requirements for medical devices connected to or equipped with an energy source
13. Information supplied by the manufacturer and clinical data
   
Risk-Analysis for Medical Devices According to EN 1441
EN 1441 provides a tool to comply with the risk-analysis requirements of the Medical Device Directive 93/42/EEC. However, EN 1441 does not cover all aspects of risk-management.
Classification of a Medical Device
Annex 9 of the Medical Device Directive provides 18 rules for the classification of a medical device. The manufacturers have to classify their product according to these rules by taking the intended use of the product into consideration.

Rules 1 to 4 are for non-invasive devices
Rules 5 to 8 are for invasive devices
Rules 9 to 12 are additional rules for active devices
Rules 13 to 18 are special rules
With the above rules, the risk of the medical device for the patient or user can be identified and categorized and thereby the conformity assessment procedure is determined.
The higher the risk, the more stringent are the requirements for the conformity assessment procedure!

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