On May 5, 2017, the European Commission released the new Europe (EU) Medical Device Regulations (MDR) in an effort to create a more unified and transparent system for medical devices.

The MDR will become enforceable in 2020, and introduces new rules relating to labeling requirements for medical devices.

Since the MDR requirements, especially those concerning Unique Device Identification (UDI) and changes to Annex I of the regulation, are completely new for the EU market, many organizations that work with medical devices are in the process of learning these next steps to increase transparency, improve traceability, and create better patient outcomes.

Here is a quick overview of some of the Annex I and UDI labeling requirements, as well as some resources and advice that will help your organization become compliant.

Annex I

According to Deloitte, 15 percent of medical device product recalls are attributed to labelling errors. In Annex I of the MDR there are several key changes that attempt to avoid this problem in the future.

One is that medical device companies must list device labeling and Instructions For Use (IFUs) on their website so they are easily accessible for consumers and healthcare providers at all times.

The MDR also states that all IFUs must be formatted appropriately to each device, include the safety and clinical performance of the device, and be written in plain language so that they can be easily understood by the end user.

These requirements emphasize the MDR’s focus on creating medical device information that is accessible and transparent for both doctors and patients.

Unique Device Identification (UDI)

The Unique Device Identification (UDI) is intended to improve the traceability of medical devices throughout the supply chain by connecting all the information about each medical device through a digital information repository called Eudamed. MDR requires that a UDI label be directly attached to a medical device or to its packaging and include two identifiers:

  • A UDI-DI (device identifier – linked to a manufacturer and device)
  • A UDI-PI (production identifier – identifies unit of device production)

Upon production of the device, the manufacturer will have to submit the UDI-DI and additional product data (such as single registration number and whether it contains latex or other specific substances) to this central database, which will be accessible to public and healthcare professionals and provide a comprehensive overview of what medical devices are available and how they work.

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Challenges and Opportunities

Taken together, Annex I and UDI impose significant new requirements on all stakeholders in the supply chain for medical devices, from manufacturers down to healthcare professionals. Here are some tips to help bring positive change in the quality of patient experiences and ease your organization’s transition to the new requirements.

Languages

With so many languages spoken in the EU, labels are often expected to be multilingual. However, UDI formatting requirements make external labeling space smaller, making it harder to include multiple languages or use languages that take up more space. Working with a language solutions partner can help your organization optimize the limited space to fulfill or exceed all requirements and best serve the consumer.

Data Management

Data security becomes of increased importance to any stakeholders who interact with the data from medical devices. These stakeholders, who may include manufacturers, distributors, and healthcare institutions, must update their quality management systems to ensure data is properly and securely stored.

Content Management

Managing label changes for multiple devices can be expensive and time-consuming. Having a clear understanding of the labeling requirements beforehand – including what technology is needed to streamline the process and what information will need to be updated most often – will help your organization prioritize resources and implement a content management system that includes a revision strategy for electronic labeling.

For more information on changes to Annex I and UDI requirements, check out ULG’s webinar on the topic.

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Life Sciences Compliance

Susan Stugelmeyer

Susan Stugelmeyer

Susan Stugelmeyer has over ten years experience supporting medical device clients with account management helping them meet their global translation initiatives. Her key areas of focus within the translation industry include driving client corporate goals throughout their global enterprise, recognizing areas of improvement and presenting solutions, and quality process.

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