After four years of transition followed by a global pandemic in 2020, we reached a regulatory milestone on May 26, 2021, for Medical Device manufacturers in the European Union – with Medical Device Regulation 2017/745 finally taking effect.
Yesterday, being the date of application of EU Medical Device Regulation (MDR) marks an important event for the medical devices market. Since the MDR’s inception more than a decade ago, the medical technology industry has fully supported the European Commission’s goals and has invested heavily to comply with the EU’s strengthened regulatory requirements, geared towards protecting patients even further and increasing trust within the EU’s legal framework.
What does this mean?
From today, May 26, 20201, EU manufacturers must meet the MDR requirements concerning Pre-Market device registration, Clinical Investigations, Post-Market Surveillance (PMS) and Vigilance. This is a requirement for all EU device manufacturers, even if a device has not yet transitioned to MDR and is currently utilising MDD 93/42/EEC (CE) certification for placement on the EU market. In addition to updating relevant Quality Management System (QMS) SOPs, device manufacturers must also create PMS and Post-Market Clinical Follow-Up (PMCF) plans for their devices to generate the relevant application data. The Person Responsible for Regulatory Compliance (PRRC) role should also be in place and operational at this time.
It is exciting to see the tremendous efforts of the medical device community to ensure continuity of the healthcare system in Europe by preparing EU MDR compliant Quality Management Systems and technical documentation.
CEO of MedTech Europe, Serge Bernasconi, said, “Medical technologies save lives, improve health and contribute to sustainable healthcare. The new Regulations are welcomed by our industry as these will strengthen patient safety and the existing robust approval system of our sector.”
What remaining work needs to be done specifically on EUDAMED?
For most Medical Device manufacturers this does not mean the conclusion of the new requirements. Instead, it marks an important first step to continue regulatory momentum and to focus on upcoming milestone dates, and ensure actions are in place to safeguard attaining and maintaining conformity for their devices. These steps will allow manufacturers to maintain the availability of devices distributed within the EU market.
How can Innovit help?
Quite frankly, medical device manufacturers have two choices. Do nothing and hope to slip through unnoticed, risking non-compliance and lost revenue. Or commit to a solid tactical plan for solution development and prepare your data for submission to EUDAMED.
We recommend starting early to prepare properly – ensuring high standards of data quality and minimising the costs and risks associated with rushed implementations. Innovit is the leading provider of data compliance solutions and our internal teams of Medical Device and In Vitro Diagnostic device IT experts communicate with EU Commission nearly every week.
The Countdown Is On!
Innovit was the first software vendor to successfully test its UDI solution with the EU Commission, having passed multiple rounds of EUDAMED machine-to-machine testing (M2M). We expect to continue testing when the next playground is released by the EU Commission in late July 2021. It’s important to understand that Innovit was the first – and only company – to successfully test its UDI solution with the EU Commission in October 2019. We were again the only solution provider to complete all test cases for both MD and IVD categories in February 2020.
We’re extremely excited to have launched our own “EUDAMED Connector playground” to help device manufacturers gather, prepare and validate their master data using the latest v7.0 data dictionary and data validation rules. Innovit’s EUDAMED Connector playground is designed to help manufacturers get a head start to prepare for M2M testing with the Commission’s before September 2021, when EUDAMED’s Device Registration module goes live!
Are you ready to make data compliance simple?
Take the first step towards successful compliance. Register for your free EUDAMED Connector trial today!