These are laid down in the ‘Essential Requirements’ of the medical devices Directives. They complement this with detailed Harmonised European Standards covering not only the products themselves but also the materials they’re made of and the tests they must pass, including standards on clinical investigations. There are also standards on how the devices must be controlled during their design and manufacture including cleanliness and sterility.
These standards are thus available to doctors, manufacturers and notified bodies alike to help determine safety and are the subject of continuous update to keep pace with the latest in science and technology. In addition there is a formal mechanism for authorities or the European Commission to intervene and de-list or augment a standard should there be a safety concern.
Authorities then select legally and technically independent, competent bodies, called Notified Bodies to independently check that manufacturers are conforming to the Directives requirements. It’s important to note here that not all bodies can check all technologies and not all Member States have notified bodies. Governments chose if they wish to designate or not a body and, if they do, they must check if the body is capable of covering the products concerned and thereafter monitor the body and its work. Notified bodies must be able to demonstrate that they have the clinical, scientific and technical competence to check the technologies for which they are designated.
Once designated, the notified body’s job, on behalf of the authorities, is to initially verify and check manufacturers against the legal requirements and standards before they market their products in the EU. In particular, and as stated in the law, for high risk devices authorities ask for an explicit prior authorization of the safety file and the manufacturer’s facilities prior to market to be carried out by the notified body. Changes to the approved design must also receive further approval from the notified body.
In addition to all this, authorities and the European Commission, together with stakeholders, develop additional guidelines to aid interpretation and implementation e.g. on Clinical investigation and clinical evaluation.
Authorities also double check on what’s going on. They monitor the body in its work, checking and monitoring the details of the files they have approved, typically once a year. They are also free to check and monitor manufacturers’ compliance with the EU legislation as part of their market surveillance.