Risk Classification and Conformity Procedure

Since medical devices include a large variety of different products, they have been arranged into several risk groups. We help you with the risk classification of your product. This is a crucial and often complex part of the CE-marking process. The conformity procedure you have to follow to fulfill the directive requirements depends on the risk group of your product.

Selecting the Notified Body

In many cases your CE Master Files must be evaluated by a Notified Body. In the Netherlands this is KEMA Medical BV. However, you are also free to choose a Notified Body in another country. There are differences in price and expertise between these institutions in the European Union. BioTop Medical advises you on your final choice.

Preparing the CE Master File

BioTop Medical assembles your product CE Master File in such a way that its assessment by the Notified Body and / or Competent Authorities will be straightforward. We search for the standards applicable to your product and translate them into a list of required compliance documents. We help you collecting those documents and review them. If you prefer, we contact directly your critical sub – contractors to help them with the selection of the materials, components and manufacturing documentation.

We write the introductory parts of the file and help you carry out the risk analysis. Moreover, we advise you on the information which must be included in the product labels and instruction for use.

We flag and offer solutions to possible shortcomings. We make sure the file is clear and complete.

Literature Search

You can often save yourself the costs of direct testing of biocompatibility and clinical research if you can support the safety and effectivity of your product by means of a literature report based on similar products on the market. 

We can look for the references, analyze the articles and process their contents into a report which complies with the guidelines given by standard ISO 14155 - 1. The report will be part of your product CE Master File.

Contact with the Notified Body

When your file has been submitted to the Notified Body, we can act on your behalf presenting the file to the Notified Body, if requested, and answering any questions they might still have. This can save you much time.