The year 2017 marked significant change for the regulation of medical devices in the European Union (EU), with the coming into force of Regulation (EU) 2017/745 [1] and Regulation (EU) 2017/746. [2] These new medical device regulations apply to those placing on the market, making available or putting into service medical devices for human use, as well as accessories for medical devices. Regulation 2017/746 relates to in-vitro medical devices. Labeling aspects are dealt with in annexes, notably Annex I Chapter 3 in Regulation (EU) 2017/745.
Why were the new EU medical device regulations introduced?
The medical devices regulations (MDRs) were introduced to take account of scientific and technological advances over the past two decades, but also due to problems interpreting previously existing regulations. The regulations divide medical devices into four risk classes, with medium or high-risk classes requiring the involvement of notified bodies [3] – organizations in member states that perform conformity assessments.
As necessary as the new medical device regulations have been, they have also posed significant challenges in terms of meeting timelines. Regulations in 2017/745 became applicable in mid-2021, but transition periods for devices already approved [4] have been extended, subject to certain conditions. At the moment, some medical devices are on a 2028 transition timeline.
Key aspects of the MDRs and artwork labeling requirements
Regulatory and artwork departments have their work cut out making sure they comply with new labeling requirements. Non-compliance can lead to costly recalls, jeopardize patient safety, and expose the company to litigation. Some of the key requirements of the regulations are:
- Better device traceability [5] through a UDI (unique device identification) in a human readable format (numeric or alphanumeric) and a machine-readable format (e.g. 1D or 2D scannable code) on the device and certain levels of packaging. CE mark, with the name of the notified body if applicable.
- EUDAMED database [6] to provide a “living picture” of medical devices. It consists of six modules dealing with “actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.”
- Broader product scope. New labeling will be required for some products (e.g. cosmetic implant materials and devices).
- Identifying a responsible person for regulatory compliance of the device, and manufacturing company details, or the name of a representative if the device is manufactured outside the EU.
- Information on any special storage and handling conditions, contents of the package, and purpose if this isn’t obvious to the user.
- Use-by time limits, date of manufacture.
User warnings, recognized symbols, use of colour, instructions for use (IFU) and many more requirements or recommendations are provided in the regulations and their annexes. Those responsible for meeting labeling requirements must also publish user information in electronic form [7] if they have a website. In all, requirements bring new challenges in creating, documenting and managing labeling.
Managing compliance with medical device labeling regulations
In the larger picture, your company should have effective quality management SOPs, which includes the validation of labeling, post-market surveillance (and important part of the MDRs) and document update workflows. Some key checklist items are:
- Plan early – New device or transitioning? If you are transitioning, your planning should be well-advanced.
- Perform a gap analysis
- Review your processes in the planning stage
- Understand regulations
- Create inventories of relevant regulations
- Train and educate
- Leverage knowledge and expertise within the organization (see Point 3)
- Bring in expertise from outside if necessary
- Closely monitor regulatory changes throughout to ensure compliance
- Create knowledge hubs
- Assign expert roles and subject matter experts (SMEs)
- Maintain databases
- Centralize document repositories
- Maintain up-to-date templates for labeling
- Implement change management
- Assign clear roles
- Seek new efficiencies in processes and technologies
- Automate and integrate your processes and workflows
- Is there scope for greater technical integration?
- Are workflows geared to compliance and best results?
- Is the company leveraging available technologies?
Managing the review approval process
Changes to EU medical device regulations also offer an opportunity to improve workflows and processes. Automation and integration are the two key elements that will position you to meet the new requirements.
TVT®, the Text Verification Tool for regulated industries is a text verification software with its modules TVT Artwork®, TVT Barcode® and TVT Spelling®. It allows you to compare an approved original document in any format with a copy (e.g. artwork file) and instantly see deviations. It is sufficiently powerful to support any document size, format or language.
Automate the process with TVT
- Using an example of an approved document in MS Word and a PDF artwork document in layout, TVT will immediately identify deviations in text, but also in artwork features that might be overlooked with the naked eye (e.g. colour deviations between artwork documents, and any deviations when working with layers, spot colours and overprints).
- TVT Barcode verifies the readability of your barcodes (1D and 2D types) on medical devices, providing grading based on ISO 15415, 15416 and the GS1 General Specifications.
- Digital and hardcopy documents are aligned perfectly. By inserting the URL of online content (e.g. IFUs on a website), the document is automatically loaded and can be compared to the approved document, or the same document in digital format (e.g. PDF) intended for printing. You will see any differences.
- Turnarounds are faster, because checks that manually take hours are completed in minutes with TVT. Timelines are reduced, because parallel approval is simplified. You will have higher quality as the document is more likely to be right the first time it is sent for review. You can expect to reduce the time spent on complex IFU updates by up to 85%.
- Version control and feedback are improved due to annotation and report functions, simplifying version corrections and creating a comprehensive audit trail audit throughout the approval process. If the printer has made a small change, you will see it immediately.
Integrate TVT into workflows
You can integrate TVT into any digital workflow system you may be using, on-premises or cloud-based. This creates seamless workflows and process steps. Integration facilitates collaborate and parallel revisions and approvals, especially when dealing with multiple projects and documents, as is the case with the new MDR requirements.
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320
- https://eur-lex.europa.eu/eli/reg/2017/746/2017-05-05
- https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies_en
- https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/faqs-on-mdr
- https://health.ec.europa.eu/system/files/2020-09/md_faq_udi_en_0.pdf
- https://ec.europa.eu/tools/eudamed/#/screen/home
- https://www.schlafenderhase.com/shblog/mdr-e-labeling
