Last month I wrote a blog on pre-market authorisation (and why this approach does not work for devices!) and thought it would be a good idea to just lay out how the European approval process for medical devices actually works. It might be a bit ‘dry’ but at least after reading this post you’ll understand the mechanics of the European system.
Authorities set the legal safety and performance requirements to be met by manufacturers for their products. 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.
Finally, to improve cooperation, the Commission helps organise the exchange of experiences between the authorities responsible for market surveillance in order to coordinate uniform implementation.
This creates a continuous loop of authority oversight of high risk medical devices. Not only does the safety file get a review by a government chosen notified body, a second additional level of oversight is applied via systematic monitoring by the public health authorities themselves, aided in their cooperation by the Commission.
This belt and braces approach has allowed Europe to efficiently and effectively ensure safety of citizens while guaranteeing the fastest access to life saving innovation to patients and doctors. Europe is able to provide technology to patients 2-3 years ahead of the USA and 5 years ahead of Japan.
Furthermore, by focussing public health authorities’ resources on the safety and public health aspects and active oversight of the system, it ensures effective use of government resources, removes any suspicion of conflict of interest - in particular where evidence points to the need to recall a device or withdraw approval - and significantly reduces the costs of the system to the public exchequer.
When having read the above, I hope it becomes clear that the system needs to make sure that all notified bodies are transparent, competent and operate to the same high level expected to satisfy all EU authorities, not only their national one. And in the same vein, to help authorities ensure the same high level of protection of citizens across the EU, the Commission must bring consistent, transparent and science-based decision making support to Member States to aid their cooperation on systematic vigilance and market surveillance; a job potentially best suited to the European Commission’s Joint Research Centre, JRC.
If you read this you have made it to the end – thank you! For those who are ‘experts’ in this stuff there is probably nothing new. For all those who are unfamiliar with the European system, I do hope that this post has clarified the workings of the system and, more importantly, helps you spot and question the various myths and half-truths that are floating around.
Director Regulatory and Technical Affairs