POSITION STATEMENT

MEDICAL DEVICE 
Aesthetic Medicine and Surgery

Reg.(EU) 2017/745

The Italian College of Scientific Societies of Aesthetic Medicine, in recent months, has started an important technical and legal examination of the new European regulation EU Reg. 2017/745 relating to Medical Devices which will come into force in May 2020, as they have been identified possible normative elements that can offer a negative interpretation for the field of Aesthetic Medicine.

The College, after having structured a large and organic position statement on the topic in multiple languages, with a view to safeguarding the health of patients and protecting aesthetic doctors and doctors from the related branches that use aesthetic medicine therapies, proposed jointly the position statement to the main Italian and European scientific companies in the Aesthetic Medicine, Dermatology and Plastic, Reconstructive and Aesthetic Surgery sector.

The European Regulation (MDR)
Eu 2017/745

View the European regulation with evidence of the critical issues found

The Position Statement worked out

View the Position Statement created to represent the critical issues

The signatory Scientific Societies

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The European Regulation (MDR)
 
 
Eu 2017/745

on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
focus element:
 

WHEREAS 12 Page 3

ARTICLE 1 POINT 3 Page13
 

Annex  XVI Page 173

 
 
 

The Position Statement
 
Worked Out
 
 
 
The signatory

Scientific Societies
 
 
 

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© 2023 Collegio Italiano delle Società Scientifiche di Medicina Estetica CF