It is always indicated that when you bring a medical device onto the European market you have to ensure that the medical device complies to the applicable legislation. But how do you know to what requirements your medical device must comply?
Annex I of the Medical Devices Directive (EU) 2017/745 outlines a list of general safety and performance requirements. These general safety and performance requirements are the essential requirements to which your medical device must comply. The essential requirements aim to ensure to reduce risks related to the medical device as far as possible. The manufacturer must ensure that his medical device complies with the essential requirements. It is therefore advisable to fully work through the list to see which requirements apply to your medical device and which are not applicable.
Chapter one of the essential requirements outlines the general requirements. Here it is explained that medical devices shall be suitable for their intended purpose and that they shall also be safe and effective. Any risks and undesirable side-effects shall be minimized and be acceptable when weighed against the evaluated benefits.
Chapter two of the essential requirements discusses the requirements regarding the design and manufacture of medical devices. Here the used substances are discussed and also the labelling of the medical device when certain substances are used.
The third and final chapter focusses on the information which should be supplied with the medical device. This chapter indicates the details of both the label and the instructions for use.
I have discussed the content of the essential requirements in a nutshell. It is of utmost importance to evaluate the essential requirements to determine which requirements are applicable on your medical device. CE Medical is fully experienced with evaluating the essential requirements for medical devices. This evaluation is part of our standard procedures with medical device regulatory projects.
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