The ever-changing landscape of medical device (MDR) and in-vitro diagnostic medical device (IVDR) regulations provides a set of challenges to your organization.
Between MDR and IVDR amendments and changing implementation dates – it is a lot to keep up with and determine how to best keep your organization in compliance. Luckily, we have been following this process carefully so you can ensure your documentation complies with translation regulation updates and utilize best practices to take advantage of cost savings.
Clearing up the MDR Regulations and IVDR Amendments
On February 16, 2023, the European Parliament voted at first reading to amend the transitional provisions in regulation (EU) 2017/745 on MDR and Regulation (EU) 2017/746 on IVDR. The approved amendment will give medical device manufacturers additional time to bring their devices into conformity with the requirements foreseen in the regulations. It will also allow more time for notified bodies to conduct conformity assessment procedures in accordance with the regulations.
Understanding the Increased Translation Requirements
Compared to the previous medical device directives (93/42/EEC, 90/385/EEC and 98/79/EC), the new MDR and IVDR have stricter and more comprehensive requirements regarding the translation of medical devices and in-vitro diagnostic devices in the European Union (EU).
- Larger number of products require localized content
- More specified requirements
- Increased emphasis on safety
- Declaration of conformity
- New Summary of Safety (and Clinical) Performance Documentation
Considerations for Translations
Twenty-four official languages are required for translation, and their choice depends on the extent of a product’s presence in the EU. Working with a language service provider (LSP) specializing in regulatory submissions, packaging, labels, IFUs, manuals, and software provides the assurance needed for compliance.
Efficiency in both cost and time lies in comprehensive preparation for your translation process.
- Consider multi-language translation while creating English content
- Think about shared content between documents
- Standardize formats
- Use an LSP that is capable of fully benefiting from translation technologies
- Leverage translation memories for cost savings
MDR and IVDR Labeling Industry Expertise
Join Morningside on March 23 from 1 PM-2 PM as we partner with MDx CRO to speak about the challenges medical device organizations face in compliance with MDR and IVDR regulations, including translations. We will have two expert speakers from the regulatory and translation industries: Carlos Galamba, the co-founder of MDx CRO and Vice President for Diagnostics at RQM+ and our very own Anna Eisenberg, Associate Director of Life Science Business Development at Morningside, a Questel Company. They provide insights into existing rules’ latest amendments and cost-effective language translation approaches.
More about our Speakers
Carlos Galamba is a seasoned professional in the diagnostics industry with a wealth of experience in both consultancy and regulatory roles. He is the co-founder of MDx CRO and Vice President for Diagnostics at RQM+, one of the world’s largest consultancies fully dedicated to Medtech. In this role, he was responsible for the overall strategic direction and subject matter leadership for diagnostics. Carlos also spent 7 years at the Notified Body BSI, where he managed, coached, and developed a global team of IVD technical experts. He was BSI’s first in-house clinician for IVDs. He led the implementation of the BSI clinical oversight process, made hundreds of CE marking recommendations for IVDs and supported IVDR Notified Body designations. Prior to BSI, Carlos held roles at the UK competent authority, the MHRA, and was a lead scientist in the UK National Health System, specializing in transfusion and transplantation medicine. He played a key role in hospital and laboratory preparedness for emerging infectious diseases, including the Ebola crisis in 2014, when the first cases were detected in Europe.
Anna Eisenberg is an Associate Director of Life Science Business Development at Morningside, with 20+ years of experience in the localization industry and a focus on life sciences. She is responsible for the company’s life science strategy and relationships with global leaders. Anna expertly advises pharmaceutical and medical device companies on best translation practices and is an expert in implementing workflows that improve quality, reduce costs, and accelerate deadlines.
About Morningside
Morningside, a Questel Company, equips the world’s leading life sciences organizations with a full suite of end-to-end language solutions for their regulatory, clinical, commercial and patent needs. With over 4,000 clients in 55 countries, we’re globally recognized for our life science expertise and technology innovation across pharma, biotech, medical devices, and healthcare. Our life sciences translation services ensure your products and ideas seamlessly reach new markets and comply with all regulatory and cultural requirements through every stage of the product lifecycle — from patent to post-market.
We hope you can join us for our webinar “Meeting MDR & IVDR Regulations: Translation & Cost Savings” on March 23rd from 1 PM-2 PM est. If you cannot make that time, please feel free to register. We will be sharing the recorded webinar with all registrants post-event. Not only will this webinar help you save time, but you will help ensure compliance in your organization and build your reputation. You won’t want to miss out on this critical presentation for the medical device industry. Register today for free attendance!
Anna Eisenberg is an Associate Director of Life Science Business Development at Morningside, with 20+ years of experience in the localization industry and a focus on life sciences. She is responsible for Morningside's life science strategy and maintaining relationships with global leaders in the field. Anna expertly advises pharmaceutical and medical device companies on best translation practices and is an expert in implementing workflows that improve quality, reduce costs, and accelerate deadlines.