What’s new?

The amended Medical Devices Directive came into force on 21 March 2010.
The amending Directive 2007/47/EC lays down stricter standards in the area of essential requirements and clinical evaluation/investigation. Furthermore, it introduces new rules for the classification of medical devices and the review of technical documentation by the notified bodies.

In recent months revised versions of numerous other standards and guidelines have been published and will now come into force. These include:

• Risk management according to ISO 14971:2009
• Medical device vigilance system according to MEDDEV 2.12-1 Rev 6 (12-2009)
• Clinical investigations according to ISO 14155-1:2009, ISO 14155-2:2009
• Clinical evaluations according to MEDDEV 2.7.1 Rev 3 (12-2009)
• Demarcation issues relating to borderline devices according to MEDDEV 2.1/3 Rev 3 (12-2009)

Now is the time to act!

The notified bodies will only be reviewing the revised requirements since 21 March 2010. Implementation is extremely urgent – as evidenced in numerous warnings issued in recent months.

Avoid capacity bottlenecks by planning ahead

Companies frequently underestimate the time and effort involved in creating and updating documents in line with the revised requirements. The sheer volume of material quickly leads to capacity bottlenecks. Intelligent forward planning therefore plays a pivotal rule in ensuring punctual completion.

You can capitalize on our extensive know-how in the area of planning and document creation

Benefit from our range of services

We can help you develop the optimum strategy – and provide flexible and rapid assistance with its implementation. The input of time and effort needed to meet the relevant requirements will depend on your product portfolio and the ‘as is’ status of your documentation.

Secure the support of our experienced team of physicians, engineers and scientists in the field of

• consulting and
• operational implementation.

We look forward to helping you in the following areas: implementation of the market monitoring process, including the necessary training activities; creation of technical documentation; fulfilment of essential requirements; formulation of clinical evaluations in compliance with MEDDEV 2.7.1. Rev3; and the resolution of demarcation issues in relation to borderline devices.