CE

Medical devices must carry a CE mark before manufacturers can introduce them into the European internal market. The CE mark also constitutes a declaration by the manufacturer that the device is in conformity with all the requirements of the Medical Devices Regulation and/or the German Medical Devices Act (Medizinproduktgesetz) (i.e. Declaration of Conformity).

The road to the CE mark varies in length depending on the device and manufacturer(s) concerned. However, applying for a CE mark always requires comprehensive documentation.

Topics

CE / Technical Documentation

Your technical documentation is the heart of your approval application. It combines information on the technical specification of your device with details of management, inspection and assessment outcomes. A clear structure and precise language will ensure that your application is accepted by relevant approval bodies, as well as by authorities in Germany and abroad.

We will be happy to help you work out what form your technical documentation needs to take, and to close any information gaps.

General Safety and Performance Requirements (GSLA)

All medical devices must comply with the basic safety and performance requirements set out in Annex I of the German medical devices Ordinance (MDR). These statutory requirements are also the basis for additional risk management measures, as well as for determining the evidence required to demonstrate the safety of the device.

We will help you to interpret these partially abstract requirements. Thus help you ensure you provide the right evidence in the right way.

Risk Management

Risk management procedures are designed to find any risks associated with your product. They help you identify and implement measures to minimise these risks. Drawing on our experience we can guide you through this complicated process and help you to identify appropriate measures.

We will show you exactly what you need to do and why.

Labelling & User Manuals

It is important that your device should be easy to understand and safe to use once it arrives on the market. However, no matter how intuitive your device, intuition always has its limits. This is where your user manuals and labelling come in.

We are able to advise you on the level of detail required in your user and operator manuals, and to help you ensure this information is clear and appropriate.

Testing

You must provide evidence of all statements you make regarding the safety and performance of your devices. We can tell you which tests you need to complete for your devices to be accepted on domestic and international markets, as well as which inspection bodies are best placed to carry them out. If you encounter a problem during testing, we can help you find a solution.

We can also provide you with an expert to guide you through the testing process.

Biocompatibility

The first step in improving biocompatibility consists of the contact classification and chemical characterisation assessments.

We can show you how to handle the EN ISO 10993 family of standards, and help you carry out the right evaluations and tests.

Usability

To make sure medical devices can be used intuitively and safely, your initial product development process must be focussed on usability.

Our experts will be happy to consult you on how to establish this process in your company,as well as achieving and documenting the desired results.

Software

Software used as a medical device is subject to various documentation requirements under the EU Medical Devices Regulation (MDR), and presents a major challenge for manufacturers.

We can advise you on what you have to record, how you have to record it, and what level of detail is required.

PMS (Post-Market Surveillance)

Clinical safety is an important component in the certification of any medical device. The clinical evaluation is followed by clinical post-market surveillance (PMS).

We will be only too happy to help you decide what information to collect during this phase, how it should be collected, and where it should be gathered. We can also advise you on how to evaluate and document this information in accordance with the applicable rules.

Clinical Evaluation

Clinical safety is an important component in the certification of any medical device, as is providing evidence of its clinical benefits.

We will be happy to explain how you can find out whether you need a clinical evaluation for your device, or whether data from literature will suffice.

PMCF

Clinical safety is an important component in the certification of any medical device. The clinical evaluation is followed by clinical post-market surveillance.

We can help you decide what information to collect during this phase, how it should be collected, and where it should be gathered. We can also advise you on how to evaluate and document this information in compliance with the applicable rules.

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