ANSWERED ON THIS PAGE:
- Which cosmetic and aesthetic products fall under EU MDR requirements?
- How should my company prepare for MDR compliance?
Preparing for EU MDR compliance
The Medical Devices Directive (MDD), Europe’s previous framework for medical device regulation and CE Marking certification, excludes most cosmetic and aesthetic products from its scope. However, the European Medical Devices Regulation 2017/745 (MDR) does cover many types of these products. As a cosmetic or aesthetic product manufacturer, are you prepared for MDR compliance now that the Regulation has come fully into force in the EU?
Cosmetic and aesthetic products falling under MDR requirements
Annex XVI of the MDR identifies the following cosmetic and aesthetic products that will have to comply with the new Regulation:
- Solid body contour modifying implants
- Liposuction equipment
- Colored contact lenses
- Dermal fillers
- Collagen implants
- Laser / Intense pulsed light (IPL) hair removal equipment
- Skin resurfacing equipment
- Tattoo removal equipment
MDR compliance means cosmetic and aesthetic product manufacturers will have to obtain CE Marking as well as maintain that certification in order to sell their products in Europe.
What EU MDR compliance means for cosmetic and aesthetic product manufacturers
Although time is short and MDR compliance entails major effort, Emergo by UL consultants are ready to work with you to identify the most efficient and effective transition strategy for your company based on the types and range of your products. We can help you establish MDR-related processes as applicable, such as:
- Determine the risk class your device falls into;
- Notified Body partnership for CE Marking certification;
- European Authorized Representation for companies without offices in Europe;
- EN ISO 13485:2016 quality management system implementation;
- Establishment of Risk Management processes;
- Identify applicable Common Specifications for your devices;
- Developing CE Marking Technical Documentation Files;
- Post-market surveillance planning;
- Clinical Evaluation Reporting (CER).
After evaluating your current operations, we can generate a comprehensive report on any MDR compliance deficiencies you may have, and recommend the most cost-effective path to get your processes in place.
We have assisted medical device manufacturers obtain CE Marking in Europe since 1997, and have the regulatory and quality expertise to get you up to speed and meet MDR requirements.