Last Updated: March 11, 2020 8:13AM
The MDR Challenge
The Date of Application of the European Medical Device Regulation (26 May 2020) is rapidly approaching as we now move into 2020. The new regulation has major implications for all stakeholders including Notified Bodies (NBs), manufacturers, Authorized Representatives, and Economic Operators. Despite the broad impact of the MDR and the release of a number of guidance documents in 2019 from the European Commission and the Medical Devices Coordination Group, there is still a gap of industry guidance and Common Specifications on how to implement and meet the new requirements. In addition, the Eudamed database to be launched under MDR has been delayed by two years to May 2022. How do you manage these uncertainties while balancing out costs, resources, and innovation for your future medical device portfolio?
The complexity and regulatory requirements of the MDR require an estimated 2-4 times more working hours from your team as well as additional budget for training, outsourcing and staff. The MDR demands more technical data generated for conformity assessments on high risk devices. It also requires plain language content generated for transparency, clinical, and vigilance purposes.
Language is no longer an add-on cost to the launch of a medical device in the European market. It is an integrated, regulated part of the medical device development, CE marking and life cycle management of medical devices. Add to these requirements the multilingual landscape of the EU and you have a solid rationale for centralizing the planning and management of your content.
What to Ask about Regulated Content in a Multilingual Market
The complexities and expanded life cycle scope of the new regulation leave little time for medical device manufacturers to look beyond Essential and Post-Market Requirements. Developing controlled, cost-effective content strategies that work across the entire life cycle of the product can drain already overtaxed resources. Just to meet the core requirements, there are numerous questions to address:
- Which NBs will be certified to assess your type of devices?
- How will UDI requirements impact your label content and designs?
- Which products should you retire from the market?
- Will your products be subject to re-classification?
- Do your products require clinical investigations? Will you need to set up a dedicated clinical unit to manage clinical trial execution for your high-risk devices?
- What are the Post-Market Surveillance and Post-Market Clinical Follow-up requirements for your devices?
- Which content will you need to submit to Eudamed?
- Which content will you publicly disclose on your products?
- Who will author non-technical content such as Summaries of Safety and Clinical Performance, Informed Consent Forms, or Implant cards? How will you manage to keep the content updated and available in local language throughout product life cycle?
- Would users and patients benefit from adding educational multimedia content to your electronic IFUs?
Why Content and Language Management are Important for Successful Implementation
The multilingual policy of the European Commission brings linguistic complication to the market’s already complex regulatory landscape. While the regulatory reforms on medical devices in Europe revolve around patient and user safety, content impacts the successful and safe use of your devices. Content that touches healthcare professionals and patients during use of your products needs to be available in local language. The MDR stipulates that language must be comprehensive, concise, clear, relevant and understandable to the subject or user. This encourages the development of patient and user content anchored in health literacy principles and linguistic expertise to tackle content in all markets. Furthermore, the multilingual policy of the European Union requires the ability to operate in 24 official languages before you obtain CE Marking and access to the European Community.
How an LSP Partnership Can Help
Partnering with a global Language Service Provider (LSP) improves your central content strategy across the life cycle of your devices in the EU. The right LSP understands your challenges. It can unburden your implementation efforts significantly and provides cost-effective content management.
Lionbridge is uniquely positioned to help you transition into MDR implementation and define a compliant EU language strategy. The sooner you act, the better you can control your Post-Market commitments and the information supplied with your devices during device development and until product retirement.
Why Partner with Lionbridge?
We’re your single global partner with extensive experience in European regulations and European Medicines Agency (EMA) procedures. We provide:
- Solid expertise on medical device content, language and health literacy principles
- Re-use of language assets enabling cost-effective communication strategies across your device portfolio
- Consistent, clear communication to users, patients and the public, which facilitates safe and correct use of your medical devices
- Smooth access to the largest single multilingual market with an aging population of over 500 million consumers that speak 24 different languages
- A partner with over 20 years’ experience with clinical trial content and Good Clinical Practice (GCP) regulated clinical investigations
- Expertise on educational content, multimedia and eLearning adapted to your users and patients
- A commitment to compliance, service and global healthcare
Our Life Science Centers of Excellence are ready to support your transition and implementation phase across all risk classes of your devices. We can translate content throughout the product life cycle into all EU languages and we can assist you in developing multimedia content for educational purposes for the benefit of users and patients. Thanks to our clinical and GCP expertise, we can also partner with you to build language assets for required during clinical investigations for your high-risk devices. Wherever you are in your search for MDR services, we can help you simplify and accelerate your road to compliance.