Brussels, 20 January 2015 - CEN is pleased to announce the publication of a new European Standard in relation to Aesthetic Surgery services (EN 16372). It is expected that this standard will help to improve the quality of these services, enhance the safety and satisfaction of patients, and reduce the risk of complications.
The market for aesthetic surgery interventions has grown over the last few years. The increased availability of affordable travel and the internet mean that medical tourism in relation to aesthetic surgery has become a reality. There is a rising need to ensure that patients are fully informed and able to rely on safe aesthetic surgery interventions, whether at home or abroad.
The new European Standard (EN 16372) addresses requirements for surgical services provided to patients who wish to change their physical appearance. This new voluntary Standard provides requirements and recommendations in relation to services provided by aesthetic surgery practitioners. These recommendations concern various aspects such as: ethics and marketing, information provided to patients, competencies of the surgeons, the consultation procedure, requirements for clinical facilities and post-operative follow-up.
The new European Standard (EN 16372) was developed by CEN’s Project Committee on 'Aesthetic Surgery and Aesthetic Non-surgical Medical services' (CEN/TC 403), which was set up in 2010. This Committee includes practitioners nominated by CEN Members as well as other stakeholders including ANEC, which represents consumer interests in standardization.
The new European Standard (EN 16372) was formally approved by CEN in October 2014 and the final version of the standard was made available to all CEN Members (National Standardization Bodies) on 17 December. Before the end of June 2015 (at the latest), this standard will be published at national level by CEN Members in 33 European countries.
The Project Committee CEN/TC 403 is chaired by Dr Johann Umschaden from Vienna (Austria), who is a Specialist in Plastic, Aesthetic and Reconstructive Surgery. Dr Umschaden states: "The new European Standard defines a high level of quality for aesthetic surgery services and provides the basis for optimal patient safety".
The Belgian Plastic Surgeon Ivar van Heijningen was one of those who initiated the project to develop a European Standard for Aesthetic Surgery services, alongside Dr Umschaden. According to Dr van Heijningen: "This European Standard is a landmark for health care services, especially considering the cross-border mobility of patients in Europe".
"Whether they are being treated in their own country or abroad, patients expect to be treated by competent practitioners in a safe environment and to be informed about relevant issues related to their treatment, including risks. These expectations are addressed by the new European Standard for aesthetic surgery services," continues Dr van Heijningen.
"Some EU member states have specific regulations on aesthetic surgery, but most countries don’t have. This gap can now be closed by the voluntary European Standard for the mutual benefit of practitioners and patients," adds Dr van Heijningen, who is the National Secretary of ISAPS (International Society of Aesthetic Plastic Surgery) in Belgium.
According to the chair of CEN/TC 403, Dr Johann Umschaden: "Even if there are specific regulations in some EU Member States on aesthetic surgery, some of them are lacking in terms of hygienic, technical issues, or they don't include a risk analysis. Recent reports on incidents in the context of Aesthetic Surgery emphasize the importance of this comprehensive European Standard, which was developed through an open, inclusive, multi-disciplinary and evidence-based process."
Speaking on behalf of ANEC, Stephen Russell, ANEC Secretary-General, says: "ANEC welcomes the publication of EN 16372. ANEC sought the inclusion of consumer relevant requirements in the standard during its development and we consider the standard satisfactory from the consumer perspective. Promoting consistently high standards for aesthetic surgery service providers across Europe is increasingly important, as more and more consumers travel abroad for aesthetic treatment."
According to Mr Russell, the new European Standard (EN 16372) could help offer assurances to consumers in countries where there are no legal requirements in this area.
The CEN Project Committee on 'Aesthetic surgery and aesthetic non-surgical medical services' (CEN/TC 403) is currently developing a separate European Standard in relation to non-surgical medical procedures (prEN 16844). CEN Members will open public enquiries in order to invite comments on this draft standard (these enquiries are due to be launched at the end of February 2015).
For more information on European standardization in relation to services, please see the CEN website: www.cen.eu/work/areas/services
CEN-CENELEC Management Centre
T: +32 2 550 08 32