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CE marking

Since June 14, 1998, medical devices may only be placed on the market in the European Union if the requirements of Directive 93/42/EEC (MDD) are met and the CE marking is affixed to the product. If necessary, additional requirements must be met in the member states. In Germany, the regulations of the national Medical Devices Act (MPG) must also be applied. A system of hazard classes and conformity modules has been set up to take account of the individual circumstances of the industry and the different degrees of risk posed by the products. Depending on the module, a notified body may have to be involved for product and/or system testing, e.g. DQS MED (identification number 0297). As a Notified Body, we are authorized to carry out certification in accordance with the MDD. We find flexible and personal solutions that are specially tailored to your individual requirements. In detail these are

Testing of technical documentation in accordance with Annex VII of the Medical Device Directive
Conformity assessment procedures in accordance with Annex II, V and VI of the Medical Device Directive

CE marking for medical devices

In principle, medical devices must bear a CE mark in order to be placed on the market for the first time in the European Economic Area. The CE-marked medical device must meet the basic requirements of European medical device law in terms of safety, performance and harmlessness to health and this must be documented in writing as part of the conformity assessment. The conformity assessment procedures and their implementation are regulated in the Medical Devices Ordinance (MPV), which refers to the corresponding annexes of the European directives. Depending on the risk class of the product, conformity is assessed and verified by the manufacturer itself or with the involvement of a notified body. The conformity assessment procedure to be carried out and the extent to which an independent testing and certification body (notified body) is involved depends on the potential risk of the products. While active implantable medical devices are not further differentiated in terms of risk, Directive 93/42/EEC (MDD) provides for a differentiation of devices into 4 classes (I, IIa, IIb, III). The classification and the conformity assessment procedure used are based on the criteria set out in Annex IX of Directive 93/42/EEC. Notified bodies carry out the prescribed tests and issue the necessary certificates. Manufacturers can contact a Notified Body of their choice that is designated for the relevant procedure and product category. DQS MED is a Notified Body (identification number 0297) of the European Union and is authorized to carry out conformity assessments in accordance with EU directives, which are mandatory for all products imported into the EU. We carry out conformity assessment procedures in accordance with Annex II, V and VI of the Medical Devices Directive and check the technical documentation against the requirements of Directive 93/42/EEC.

CE certification of medical devices by DQS MED enables you to further exploit potential in developed markets and enter new national and international markets with the necessary tests and products that comply with regulations. You can also mitigate risks and liability obligations in your chosen markets.

Before you place a medical device on the European market or put it into operation, your medical devices must bear a CE mark. A medical device is an object or substance that is used for medical, therapeutic or diagnostic purposes for humans, whereby the intended main effect, in contrast to medicinal products, is not primarily pharmacological, metabolic or immunological, but physical or physicochemical. The CE mark is not a quality mark and is not intended for consumers. It is a legally binding statement by the manufacturer that his product fulfills all the requirements of the Medical Device Directive 93/42/EEC.

Product approval by DQS MED enables you to further exploit potentials in developed markets and to enter new national and international markets with the required certification and products that comply with regulations. The approvals give you a clear competitive advantage. You also mitigate risks and liability obligations in your chosen markets.

Author

Szymon Kurdyn

Szymon Kurdyn is Head of the Notified Body (non-active medical devices) and Product Manager for ISO 13485 (DAkkS accreditation). In this position, he keeps an eye on the regulatory and normative framework of certification activities, is in close contact with authorities, our experts and our customers and informs about changes and other relevant topics.

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