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.
Contact us to learn more about EU Medical Devices Regulation compliance and CE Marking.
Additional services for Europe:
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- CE Mark Certification for Medical Devices
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- European Union Medical Device Classification
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- EU Medical Device Vigilance Reporting in Europe
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training