Doctors and medical professionals deal with sophisticated medical products on an everyday basis. According to European directives manufacturers of medical devices, depending on the classification of medical devices, must refer to a Notified Body for the certification of the same devices.
TÜV Rheinland is a Notified Body for all medical devices. TÜV Rheinland certifies devices and QM Systems for the European Market and it is also a certification Body for non-European countries.
According to the MDD 93/42/EC, Article 1, the definition of a medical device is:
· "an 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 any injury or handicap;
· investigation, replacement or modification of the anatomy or of a physiological process;
· control of conception.
and 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 Process
1. Classification of the Medical Device
Medical devices are divided into four risk classes (I, IIa, IIb, III) based on 18 rules defined in Annex IX of the MDD. The most stringent requirements are applicable to class III devices, the least stringent requirements to class I devices.
2. Selection of a Conformity Assessment Process
Manufacturers can choose between several conformity assessment processes, depending on the classification of the medical device. Except for class I devices that are sold non-sterile and do not have a measuring function, any conformity assessment process involves a Notified Body.
3. Achieving Compliance to the Essential Requirements
Regardless of the classification, compliance to all applicable Essential Requirements is mandatory for Medical Devices. Compliance can be demonstrated through testing to applicable harmonized standards. (e.g. EN 60601-1 for electrical safety).
4. Implementation of a Quality Assurance System
Most manufacturers choose a conformity assessment process that includes an assessment of the Quality Assurance System.
5. Creation of a Technical File or Design Dossier
The objective of the technical documentation is to demonstrate conformity to the directive. Thus, the technical documentation includes elements of Design History files and elements of Device Master Records.
6. Conformity Assessment by a Notified Body
The conformity assessment by a Notified Body can take various forms, such as Type Examination, Batch Verification or Quality System Assessment, depending on the conformity assessment process.
7. Declaration of Conformity
The final step of the conformity assessment process is the Declaration of Conformity to the Directive.
The "Essential Requirements" of the MDD shall be supported by test reports based on harmonized standards (ENs). The use of harmonized standards presumes compliance with the Essential Requirements (Annex I). The tests can be completed by a first, second or third-party organization, which would be affiliated with a Notified Body.
