An article on medical devices – such as implants and artificial hips – published in Daily Mail on 29 June contains serious inaccuracies and leaves out crucial points. In particular, it misrepresents the current system for the approval of such devices and neglects to point out that the EU has taken a series of important steps to strengthen that system.
According to the article, “Brussels” and the European Commission approve unsafe high-risk medical devices on the EU market.
This is not the case.
Under EU legislation, independent third-party organisations (Notified Bodies) check and scrutinise medical devices before their CE certification and possible placing on the market. These Notified Bodies are designated and monitored by national authorities, not by “Brussels”.
In other words, the European Commission does not play a direct role in the authorisation of medical devices. It is up to the certifying organisations supervised by national authorities to ensure they are safe.
What the Commission has done is to step in following the recent issues over PIP breast implants. This scandal was the result of fraud. Although no system is completely foolproof, the scandal highlighted a need to reinforce aspects of the system and introduce greater surveillance of devices before they are placed on the market, as well as of those already on the market.
That is being done under a joint action plan negotiated with Member States and already being implemented. For example, audits of Notified Bodies have been reinforced and corrective action taken where deficiencies were identified. Coordination between national authorities has been strengthened. And the Commission recommended that national authorities carry out unannounced audits of manufacturers.
Even more importantly in the long run, the Commission proposed – it has no powers to impose – new EU rules which Member States and the European Parliament are now on the verge of approving. The new rules among other things aim to:
– introduce for high-risk implantable devices a new procedure for consultation of a European pool of experts, in addition to the current certification procedure;
– ensure implants for aesthetic purposes are fully covered by the system;
– boost national supervision of notified bodies, including post-market surveillance;
– increase the powers of notified bodies over manufacturers, including the right and duty to carry out unannounced factory inspections and to conduct tests on medical devices to ensure continuous compliance by manufacturers after receipt of the original certification;
– extend the Eudamed database on medical devices available on the EU market, ensuring that clinical data is made public;
– improve the traceability of medical devices;
– introduce stricter requirements for clinical evidence to support assessments of medical devices;
– incorporate international guidelines into EU law.
The Daily Mail chooses not to mention any of the above.
The reformed system will further improve safeguards while preserving the principle of decentralised scrutiny. It allows European countries to ensure a high level of patient safety while also, as the Mail does acknowledge, ensuring quicker access than in the US to effective new technologies for patients.
In the medical arena, there is always a difficult balance to be achieved between implementing innovation quickly and minimising risk. Interestingly, in another context recently, the Daily Mail criticised the EU system of medicines approval for, in its view, being slower than the US one. We responded to that here:https://blogs.ec.europa.eu/ECintheUK/the-eu-is-investing-billions-in-tackling-cancer-not-denying-treatment/#more-2758