Business Brunch Medical Device Regulation
New obligations and liability risks!
Business brunch with Miriam Schuh on 23 June 2017 in Düsseldorf
The MDR and the IVDR are now available in their final amendment and will be coming into force in the summer of 2017. The manufacturers of medical devices will have to face a large number of new obligations and challenges.
Conditions governing the responsibility of manufacturers for monitoring the performance, quality and safety of their products have been made more stringent. With these regulations, the implementation of the quality management system is being standardised in statutory terms for the first time; manufacturers’ product surveillance systems are being redefined, requirements relating to technical documentation and CAPA obligations intensified. Clinical tests will in future require to be carried out over the entire life cycle of a medical device. Provision is to be made for liability in the case of defective products, and that will tie up additional resources. In addition, there are UDI product labelling obligations and wide-ranging reporting obligations in respect of EUDAMED.
At the same time, manufacturers are required to implement the requirements of MEDDEV 2.71/1 rev. 4 organisationally and to carry out the certification of their quality management system in accordance with DIN EN ISO 13485:2016.
As from the time when the MDR and the IVDR come into force, the target for manufacturers must be to make a structured analysis of what requirements actually arise from the regulations and to prepare themselves in organisational terms for the CE marking in accordance with the new standards.
We look forward to discussing these topics with you at our business brunch.