Decisions need to be made by consensus, however. ‘This is the main issue; it can be difficult at EU level — it is not an easy task.’ If there is conflict, a deviation can be raised — stricter than a European standard — for implementation in national law only.

In his role, managing the debate and pursuing best practice, Mr Regan has seen the vast differences, variations and approaches across Europe. He adds, however, that the Austrian secretariat is ‘doing a good job’ in what is the biggest move towards EU standardisation in this area. The CEN standards could even become an ISO standard — a worldwide standard.

Mr Regan’s task at hand is to bring experts together, achieve an understanding of standards and regulations, and agree on a statement of best practice. ‘In my opinion, the initiative is a good thing. It puts patient safety at the forefront, where it should be.’

Conclusions

CEN European standards are voluntary, but their impact is significant, says CEN communications manager Celine Oeyen. ‘They help consumers make intelligent choices and create a level playing field for service providers, and fill gaps in existing legislation.’

Ultimately, with an agreed CEN standard, enhanced powers for the authorities to police manufacturers, and generally better awareness of the serious nature of cosmetic surgery (and implantables in particular), a repeat of the PIP scandal should be avoided.