Shekh Emran, PhD, Validation Specialist
The EU MDR (the EU 2017/745 medical-device regulation) was published in 2017, replacing previous directives and regulating basic requirements, classification, and conformity assessment procedures for medical devices and in vitro diagnostics. As of May 26, 2021, medical device companies must comply with the new regulation. The word “safety” appears 290 times in the MDR. The MDD, by comparison, uses it only 40 times. Its goal is to ensure safety, transparency, and innovation in the industry, but implementing its requirements can be challenging for companies.
Ensuring Compliance with EU MDR Requirements
Medical device manufacturers must now submit an EU certificate according to EU MDR for placing products on the market. However, not all actors in the supply chain are yet familiar with the new requirements and there are still urgent questions that need to be answered by the EU Commission. All economic actors involved throughout the entire life cycle of the medical device need to ensure compliance with the EU MDR requirements.
The new EU MDR has made numerous requirements more stringent, added new requirements such as GSPRs, introduced ambitious requirements for Quality Management System, and reclassified some products to higher risk classes. ISO 13485:2016 is expected as a standard, a PRRC is required, and a Scrutiny procedure has been introduced. Reporting deadlines and market surveillance have been reorganized, and PLM/OEM constellations no longer exist.
The Significance of Validation in Medical Device
Validation is a crucial part of medical device development, where various tests are conducted to assess the device’s performance, reliability, and safety. Documentation of the testing process and results is also critical for regulatory compliance and to showcase the device’s safety and effectiveness to users and stakeholders. This documentation consists of a validation plan, test protocols, and a validation report. According to the MDR, medical device validation must be conducted in accordance with internationally recognized standards, such as ISO 13485 and ISO 14971.
Feicon Oy’s Expert Medical Device Validation Services
Feicon Oy can provides expert medical device validation services that comply with the stringent EU Medical Device Regulation (MDR). Our experienced team helps manufacturers navigate regulatory requirements and deliver safe, effective, and compliant devices. We offer customized solutions that streamline validation and reduce time to market, including a validation plan, test protocols, and a validation report. Trust us to ensure the success of your device and the safety of patients worldwide. Contact Feicon Oy for your medical device validation needs.