The world's leading automated proofreading software

September 22, 2021

The Schlafender Hase Team

MDR UDI and Device Registration

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 :

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

Related Blogs

September 20, 2023

Schlafender Hase Team

Top Medical Device use document comparison software to proofread labeling. Why aren’t you?

When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Medical Device industry, however, proofreading is a whole lot more than that. Packaging and labeling can include many elements such as instructions for use, company logo, symbols and numerous other graphics, as well as a variety of different barcodes. Everything has a purpose and must be correct before a device goes to market.

September 18, 2023

Schlafender Hase Team

5 Must-Do Activities in Montreal During RAPS Convergence 2023

Welcome, esteemed professionals attending RAPS Convergence in Montreal! To help you experience the best of what Montreal has to offer, we've compiled a list of five must-do activities during your visit. Get ready to explore the charm and excitement of this captivating Canadian metropolis!

September 15, 2023

Schlafender Hase Team

A Guide to Purchasing Proofreading Software for Regulated Industries

Have you identified the need for a solution to compare text and graphics in your organization, but need some help with the complete process of identifying, evaluating, and acquiring the right solution?