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Licensing and CE Marking for Germany

Show us the product and we'll take care of the rest

We can assist you in the CE certification and registration for the German and European market.

The manufacturing and importing of medical products and medical equipment is heavily regulated in Germany and the European Union.
Medical products being marketed for the first time have to fulfill certain regulations and disclosure obligations. This applies to manufacturers in Germany as well as ones from the EU and from non-EU states such as the USA.

For instance, manufacturers and importers must:
> Register their activities with the German Institute of Medical Documentation and Information (DIDMI).
> Nominate an accredited safety officer for their products and register that person with the DIDMI.
> Submit conformity assessments and the corresponding marks and labels.

Conformity assessments and CE Marks
Manufacturers of medical products have to demonstrate that they comply with the European Union's "essential requirements" as described in Directive 93/42/EEC. For this purpose, a conformity assessment procedure must be performed for each medical product. The scope of this procedure depends on the risk category to which the product belongs.

A government-accredited institution known as a 'notified body' has to be appointed to perform the conformity assessment procedure on any medical products that do not belong to category 1, or that do belong to category 1 and have a measurement function, or that belong to category 1 and have to be used in a sterile state.

Once the conformity assessment procedure has been done, the manufacturer issues a certificate of conformity and is then entitled and obliged to apply the CE Mark to the medical product before launching it on the market.

Exceptions to the obligation to carry a CE Mark apply to special one-off products, medical products produced by an entity which only intends to use them internally, medical products that are to be subjected to clinical testing before being marketed, and in-vitro diagnostic products that are to be subjected to a performance appraisal before being launched on the market. Medical products that carry a CE Mark by law can be marketed within the whole European Union.


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Our Service:

We take care of all the handling required to certify your products on the German and EU healthcare market.

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