Medical Device Regulation in the EU
Best Practices by Team NB
On 19th April – the team notified bodies [Team NB] published a position paper highlighting the Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745. Click here to access the full docuement.
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.
This technical documentation submission guidance is aligned to the requirements of Medical Devices Regulation [MDR] (EU) 2017/745, described in detail in Annexes II and III of Regulation (EU) 2017/745.
Annex II and Annex III combined outline requirements for the content of the Technical Documentation required to demonstrate the conformity to Regulation 2017/745. In basic terms, Annex II states this documentation must include information about the device's design, manufacturing processes, labeling and packaging, risk analysis and clinical evaluation. As well as information on any software or accessories associated with the device. Annex III outlines the requirements for documentation on Post-Market Surveillance (PMS), including the minimum contents of the PMS plan and report. Where applicable to the nature and risk classification of the device, Annex III also requires Post-Market Clinical Follow Up (PMCF) and Periodic Safety Update Report (PSUR). Importantly, whilst Annex II and III state that Technical Documentation must be presented in a clear, organised, readily searchable and unambiguous manner, they do not give any specific guidance on layout, format or structure. [Read More by clicking here] - https://med-di-dia.com/blog/annex-ii-eu-mdr
Before moving into the main aspects of the document, the Team NB has mentioned that The most common reasons for delays in Technical Documentation reviews by notified bodies are:
- Incomplete Submissions – Insufficient or missing information not provided that is required for the conformity assessment activities. This includes an incomplete or inconsistent description of devices covered by the application and the related Technical Documentation (variants, accessories, combined devices covered by the Basic UDI-DI to be assessed).
- Lack of Cohesive Structure of Technical Documentation - The information is presented within the Technical Documentation but is difficult to locate.
Any delay in certification can affect your market entry and sales plan. Experts suggest that Medical Device Manufacturers must focus on providing a 360-degree view of their devices through effective and efficient documentation.
We are here to present end-to-end support by creating a submission strategy, creating the technical documentation, liaising with the notified body and acing all the RAQA requirements for your devices!
Feel free to drop us an email – mdd@mddltd.com or fill out an interest form - https://mailchi.mp/686b393380fc/bvmauwj29a
Contents of this document are as follows:
Ø Device Description & Specifications - Including Variants, Accessories, Classification & Materials
Ø Device description and specification details should include:
Ø Reference to previous and similar generations of the device
Ø Information to be supplied by the manufacturer (Includes Declaration of Conformity, Labelling, IFU, Implant Card, Surgical Technique brochure etc.)
Ø Design & Manufacturing Information
Ø Sites and Subcontractors
Ø General Safety & Performance Requirements (GSPRs)
Ø Benefit Risk Analysis and Risk Management
Ø Product Verification and Validation
Ø Biocompatibility
Ø Software & Software Validation (Including Cyber Security)
Ø Electrical Safety and Electromagnetic Compatibility (EMC)
Ø Packaging, Stability and Shelf-Life
Ø Performance and Safety - Design Verification and Validations (including devices with a measuring or diagnostic function, MR Compatibility)
Ø Usability
Ø Devices Incorporating Medicinal and Biological Materials
Ø Drug/Device Combination Products
Ø Human Origin Matter
Ø Animal Origin Matter
Ø Biological Origin Matter
Ø Substances absorbed or locally dispersed
Ø Hazardous substances, CMR, endocrine disrupting substances
Ø Sterilisation & Reusable Surgical Instruments
Ø Clinical Evaluation (Includes SSCP labelling)
Ø Post Market Surveillance
Some of the key aspects highlighted in the paper include:
- The need for clarity and harmonisation in interpreting and implementing MDR requirements across all Member States and stakeholders.
- The challenges and delays faced by Notified Bodies in obtaining designation under the new MDR due to the increased requirements and resource constraints.
- The importance of adequate resources and investments by Notified Bodies and manufacturers to ensure compliance with the MDR.
- The need for a risk-based approach to regulatory oversight that takes into account the level of risk associated with a device and the intended use.
- The importance of data and evidence-based decision-making in the assessment and approval of medical devices.
- The need for transparent communication and collaboration between all stakeholders, including Notified Bodies, manufacturers, regulatory authorities, and healthcare professionals.
- The impact of the MDR on innovation and the development of new medical devices, particularly for small and medium-sized enterprises (SMEs).
- Overall, the position paper stresses the importance of effective implementation and enforcement of the MDR to ensure the safety and efficacy of medical devices and to support innovation and competitiveness in the EU medical device industry.
Our experts come across several requests where the certificate is rejected because of incomplete documentation or a situation where a product doesn’t have valid IFU, Labelling and other requirements.
These small factors can lead to cessation of sales, penalties, fines and/or imprisonment!
Why risk your EU sales when our experts are here to be your Regulatory Risk Partners?
Feel free to drop us an email – mdd@mddltd.com or fill out an interest form - https://mailchi.mp/686b393380fc/bvmauwj29a
Contact us with any RAQA challenge; the rest will be taken care of!
