EU-MDR CE certification
We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
Our service covers all CE certification activities, including:
- CE MDR Review & Gap Analysis
- MDD-MDR transition
- Initial MDR CE certification
- CE marking for Class I manufacturers
- Pre-review of Technical Files
- Writing of Clinical Evaluation, Literature and PMS-PMCF plan & report
- CE audit management
- PRRC (Person Responsible for Regulatory Compliance) service
- Liaison with regulatory parties (Notified bodies, Authorized Representatives, Competent Authorities) and
- EU-MDR auditing & training
For more information, please contact the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.