Medical Device Certification is the process that enables manufacturers to legally sell their products in the Turkish and European markets by obtaining CE marking in accordance with the 2017/745/EU MDR (Medical Device Regulation). Also referred to as MDR Certification, this process covers many stages — from product classification to Technical Documentation preparation, from Notified Body assessment to CE marking. At Conformed, with over 17 years of industry experience, we stand by Medical Device Manufacturers at every step of the MDR and Medical Device Certification process.
How Does the Medical Device Certification Process Work?
While the MDR Certification process varies depending on the risk class of the product, it generally consists of the following stages:
- Product Classification: Determining the device’s risk class (I, IIa, IIb, III) based on its intended use, duration of use, and degree of invasiveness.
- ISO 13485 Quality Management System Setup: Aligning production and quality processes with international standards.
- Technical Documentation Preparation: Creating the technical documentation, including clinical evaluation, risk management, and biological evaluation studies.
- Clinical Evaluation: Supporting the device’s safety and performance with clinical data.
- Notified Body Assessment and CE Marking: Undergoing a conformity assessment by an independent Notified Body — required for all devices except Class I — and obtaining the CE mark.
- Post-Market Surveillance (PMS): Continuously monitoring the device’s safety after it has been placed on the market.
MDR Certification or Medical Device Certification?
In practice, both terms are used to describe the same process. “MDR Certification” refers to the current European regulation (2017/745/EU) on which the process is based, while “Medical Device Certification” is a more general term. Regardless of which term you search for, the consulting service we provide at Conformed covers the same comprehensive process.
Why Work With Conformed?
Over our 17 years in the industry, we have worked with more than 150 Medical Device Manufacturers and 250 Medical Devices to complete the certification process. With our expert team, who provide Training and Consulting services exclusively to Medical Device Manufacturers for ISO 13485 and MDR Certification processes, we ensure your products reach the Turkish and European markets safely and in full regulatory compliance.
To learn more about your MDR Certification or Medical Device Certification process, contact us.