This is the first of four weekly blogs relating to Medical Devices Regulation (MDR)
The new European Database on Medical Devices, known as EUDAMED, was originally scheduled to launch in May 2020, but the pandemic has caused a 2-year delay. Some EUDAMED modules will be made available to users before the official launch date of May 26, 2022. The second module, for instance, on UDI/Device registration and the third module on Certificates and Notified Bodies are due to be released in late September 2021. The remaining modules will be displayed as soon as they become functional.
Content posted to this database must be error-free. Are you aware that software and technology is available to help you to achieve this accuracy? Importantly, as this content is transformed, revised and published over the product’s lifecycle, these solutions will also support verifying and reporting those revisions to prove compliance.
Medical Device Regulations (MDR) will also bring further scrutiny of technical documentation, including clinical evaluation, post-market clinical follow-up, and traceability of devices throughout the supply chain.
Every manufacturer is aware of the consequences of labeling and data errors, especially in the medical device sector. Errors do not just threaten patient health, they can also lead to Corrective and Preventive Actions (CAPAs) and costly revision cycles, reprints or recalls that ultimately damage a company’s financial performance. Accuracy and right-first-time should therefore be the key focus.
Using an automated proofreading solution to verify all your data and labeling collateral will ensure content has been accurately collated and updated, with a full audit trail to prove compliance.
Whatever route you are using—manual input through the EUDAMED User Interface or bulk uploads via XML import—Schlafender Hase’s TVT proofreading solution can ensure your data is error-free.
Read how medical device supplier Lohmann & Rauscher reduced their IFU proofreading time from TEN hours to ONE hour by implementing TVT :
