December-24 Insights: Navigating MedTech Compliance

How to Manage Medical Device Design History File (DHF)

Effectively managing a Design History File (DHF) is crucial for ensuring regulatory compliance in the development of medical devices. The DHF provides documented evidence of the design process, ensuring that each phase meets regulatory standards and helps in maintaining the integrity of the design.

Read the full article for a deeper understanding of managing your DHF and its importance for medical device developers. Read more.

Swissmedic Releases New Guidance Document: Product Information for Human Medicinal Products

Swissmedic has published a new guidance document that outlines the requirements for product information for human medicinal products. This document is primarily aimed at administrative bodies, with the goal of clarifying specific requirements for applicants to ensure quick and efficient processing of product information texts.

Read the full document for an in-depth understanding of the new guidance and its implications for healthcare product developers. Read more.

Season’s Greetings from TS Quality & Engineering!

As we approach the end of the year, we want to extend our heartfelt gratitude to all the dedicated professionals in healthcare and compliance. Your unwavering commitment to ensuring the safety, quality, and effectiveness of medical devices and healthcare products is truly inspiring.

This holiday season, we celebrate the spirit of collaboration and innovation that drives our industry forward. May this festive season bring you joy, peace, and a well-deserved break to recharge for the exciting year ahead.

Thank you for your hard work and dedication. We look forward to continuing our journey together in the coming year, making strides towards excellence in healthcare and compliance.

Wishing you and your loved ones a happy and healthy holiday season!

The TS Quality & Engineering Team

Guidance for Investigator’s Brochure (IB) – Medical Devices

Medical device manufacturers face various regulatory requirements worldwide. One critical document for clinical investigations is the Investigator’s Brochure (IB), mandated under Article 70(1) of EU MDR 2017/745 and detailed in the MDCG document, 2024-25.

Key Points:

• Purpose: The IB provides clinical and technical data about a medical device for investigators, ensuring they can make informed decisions.
• Contents: Includes clinical and non-clinical information presented concisely and objectively to aid in unbiased benefit-risk analysis.
• Importance: Ensures the safe and correct use of the device and serves as a stand-alone document for potential investigators.

Read the full article for detailed guidance on preparing an effective Investigator’s Brochure. Read more.

MDR Technical Documentation Training for Manufacturers

Medical device manufacturers must navigate various regulatory requirements, including those outlined in the Medical Device Regulation (MDR) 2017/745. To assist manufacturers, TEAM-NB is offering a training session focused on MDR technical documentation requirements.

Read the full document for detailed guidance on preparing technical documentation under MDR. Read more.

MHRA UK: Medical Devices Regulatory Reform Roadmap to Implementation Version 2.0 (December 2024)

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has released Version 2.0 of its roadmap for implementing medical devices regulatory reform. This document outlines the intended timelines and milestones for the future regulatory framework, aiming to enhance patient safety and streamline market access for medical devices.

Key Points:

• Purpose: To introduce new regulations prioritizing patient safety and ensuring the UK remains an attractive market for medical technology innovators.
• Timeline: Includes statutory instruments debated and made law, new regulations for post-market surveillance, and consultations on international reliance and in vitro diagnostics.
• Transitional Arrangements: CE marked medical devices will continue to be accepted on the Great Britain market with specific timelines for compliance.

Read the full document for detailed insights into the MHRA's regulatory reform roadmap. Read more.

Artificial Intelligence in Medical Devices Questionnaire

The German Notified Bodies Alliance for Medical Devices and Team NB have jointly published an insightful position paper titled "Artificial Intelligence in Medical Devices Questionnaire." This document, edited by the Team-NB AI Task Force and IG-NB Arbeitskreis Digitales, provides a comprehensive overview of the key considerations and regulatory requirements for integrating AI in medical devices.

Key Points:

• Purpose: To outline the regulatory expectations and provide guidance for manufacturers on the application of AI in medical devices.
• Collaboration: Jointly adopted by major European regulatory bodies, emphasizing the importance of harmonized standards across the EU.
• Version 1: The initial release, dated 14/11/2024, sets the foundation for ongoing updates and enhancements.

Read the full document for detailed insights into the AI regulatory landscape and how it impacts medical device development.

European Commission Report on Single-Use Devices and Reprocessing

The European Commission has released a significant report to the European Parliament and the Council on the operation of Article 17 of Regulation (EU) 2017/745. This regulation addresses the reprocessing of single-use medical devices, which is a crucial aspect for enhancing sustainability and regulatory compliance in healthcare.

Key Points:

• Purpose: To evaluate the effectiveness and operation of Article 17 concerning single-use devices and their reprocessing.
• Scope: Covers the impact on public health and the environment, along with compliance measures within the EU.
• Findings: Highlights the benefits of reprocessing single-use devices, including cost savings and reduced environmental footprint.

Read the full report for a comprehensive understanding of the regulation's impact and future implications for healthcare providers and manufacturers.

MedTech Europe Position Paper: Smooth Transition to Mandatory Use of EUDAMED

MedTech Europe has released a position paper outlining industry perspectives on transitioning to the mandatory use of EUDAMED, the European database for medical devices. The paper emphasizes the need for efficient resource use, improved accessibility, and consistency through technical and regulatory measures.

Key Points:

• Purpose: To ensure a smooth transition to EUDAMED, addressing usability challenges and providing adequate support for users.
• Scope: Focuses on the implementation of EUDAMED as a critical infrastructure for the In Vitro Diagnostics (IVD) and Medical Devices (MD) Regulations.
• Benefits: Enhances regulatory oversight, collaboration between Competent Authorities and users, and transparency for the public.

Read the full position paper for detailed insights into the industry's recommendations for a seamless transition to EUDAMED.

Approaching Supplier Corrective Action Requests

Suppliers play a crucial role in the medical device manufacturing industry. When a supplier makes a mistake, it is referred to as a non-conformity, which can have significant repercussions depending on its severity. Fortunately, there is a formal system known as the Corrective Action Request (CAR) to address such non-conformities.

Key Points:

• Purpose of CAR: A formal request to resolve non-conformities within an organization's Quality Management System (QMS).
• ISO 13485 Compliance: CAR is essential for ISO 13485:2016 certification, ensuring quality management standards.
• SCAR: A specialized type of CAR focused on supplier-related issues, emphasizing supplier oversight and corrective actions.

Read the full article for a comprehensive guide on CARs and their critical role in quality management.

EU Reforms in Medical Device and In Vitro Diagnostic Medical Device Regulations

The Council of the European Union has issued a note highlighting necessary reforms in the Medical Device and In Vitro Diagnostic Medical Device Regulations (MDR and IVDR). These reforms aim to streamline the implementation process, which has encountered various legislative delays and challenges.

Key Points:

• Purpose: To ensure product safety across the EU through effective regulatory frameworks for medical devices and in vitro diagnostics.
• Legislative Actions: Recent actions include extended transition times for IVDR and the introduction of important provisions on EUDAMED and market interruption notification systems.
• Collaborating Countries: The reforms are supported by Croatia, Finland, France, Germany, Ireland, Luxembourg, Malta, Romania, and Slovenia.

Read the full document for an in-depth understanding of the regulatory reforms and their implications for medical device manufacturers.

?? Breaking: MDCG 2024-15 Guidance Is Here! ??

In the ever-evolving world of medical device regulations, staying compliant means staying informed. The latest MDCG guidance addresses clinical investigation reports and summaries in the absence of EUDAMED, ensuring transparency while we wait for the system to go live.

?? Why This Matters: This guidance supports MDR Article 77 and ensures a critical balance between regulatory compliance and public transparency. For sponsors, it’s both a challenge and an opportunity to strengthen trust and accountability.

Read the full document for more details on this essential guidance.

Team-NB Publishes Position on Regulatory Framework for Medical Devices

Team-NB, the European Association of Medical Devices Notified Bodies, has released a position paper on the regulatory framework for the medical devices sector. The paper emphasizes the need for a robust, transparent, and sustainable regulatory system that ensures high levels of safety and health while supporting innovation.

Key Points:

• Purpose: To establish a regulatory framework that balances safety, transparency, and innovation in the medical device industry.
• High-Level Objectives: Focus on improving health access, harmonizing designation and monitoring of Notified Bodies, and increasing transparency.
• Support for SMEs: Highlighting the importance of small and medium-sized enterprises (SMEs) in the sector and advocating for increased EU-level financial support.

Read the full position paper for detailed insights and recommendations from Team-NB.