TÜV Rheinland Medical Devices

We look forward to seeing you at one of our three Lunch & Learn Seminars in the USA. Register now!

New EU AI Act: What medical device companies need to know The European AI Act is coming into force on August 2, 2024. Is your company ready? Our latest blog post breaks down: 🔷 Key points of the legislation 🔷 Impact on medical device industry 🔷 Steps for compliance 🔷 Implementation timeline Don't risk market access in the EU. Get informed now! Read the full article written by Ferenc Kazinczi, Global Head Medical Software (TCC) and Dr. Andreas Schwab, Deputy Global Head Medical Software (TCC) #EUAIAct #MedicalDevices #AIRegulation #HealthcareTech

We look forward to seeing you at one of our three Lunch & Learn Seminars in the USA. Register now!

📣 Regulatory Update: Regulation (EU) 2024/1860   On July 9, Regulation (EU) 2024/1860 was published in the Official Journal of the European Union and entered into force. The regulation amends regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) and covers the following three topics - The gradual roll-out of EUDAMED as the different modules become available - The obligation of manufacturers to inform the public in case of interruption or discontinuation of supply - Transitional provisions for certain in vitro diagnostic medical devices (IVDs).   One of the most significant changes resulting from the new regulation is the extension of the IVDR transition period for legacy devices already supplied under the Directive 98/79/EC (IVDD). Devices that have been withdrawn from the scope of IVDD certification or that have undergone a significant change cannot benefit from the new transitional provisions unless specific conditions are met. The new transitional provisions ensure continuity of supply of IVDs to the market, while giving manufacturers and Notified Bodies time to approve legacy devices under the IVDR. Manufacturers of legacy IVDs must have a signed agreement with their Notified Body for a conformity assessment and have lodged an application for IVDR certification to benefit from the extended transition periods. They must also have implemented QMS requirements under the IVDR before May 26, 2025.   As one of the first Notified Bodies to receive notifications for IVDs under the IVDR, TÜV Rheinland welcomes the new timeframes and will support customers during the extended transition process. It is important that manufacturers continue to work towards the transition to avoid Notified Bodies being overloaded with review and certification under the new timeframes. TÜV Rheinland will prepare all relevant procedures and templates to ensure a smooth transition and keep you updated.

📣 Regulatory Update: MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices   The latest revision provides guidance on the use of standards in the medical devices sector, supporting EU legislation. It refers to the EU's "New Approach" and "New Legislative Framework," detailing the role of harmonized European standards (hENs) in ensuring devices meet essential requirements. The document outlines the process for developing hENs, and their publication in the Official Journal of the European Union (OJEU) to confer presumption of conformity. It also discusses the international aspects of standardization, the concept of "state of the art," and the Court of Justice of the European Union's rulings on standardization. Additionally, it addresses the European Pharmacopoeia and common specifications. The governance structure for standards in the medical devices sector includes the MDCG Subgroup on Standards and the CEN-CENELEC Sector Forum on Healthcare Standards. The document emphasizes that while using standards is voluntary (with one exception in the MDR proving the rule), compliance with legal requirements is mandatory. Choosing to use a standard or not belongs to the manufacturer’s sole responsibility for the device. Notified bodies performing conformity assessment activities must check whether the concerned device complies with the requirements of the Regulations on medical devices. In this regard, they require notified bodies to take into account the state-of-the-art by taking into consideration available CS, guidance and best practice documents and harmonised standards, this even if the manufacturer does not claim to be in compliance. The current revision includes several changes to the document, to include current communications, task force procedures and guidance, rulings of the court of justice of the European Union, and to add more references to related standards, guidelines and international working groups. Also updates regarding the standardization request and HAS consultants supporting the harmonization process are inserted. The revision includes updates on the guidance for understanding the concept of “taking into account the state-of-the-art”, and the limitations of the application of standards in the context of establishing conformity to the legal requirements for medical devices. Furthermore, sections concerning the reference to Ph.Eur. and Common Specifications have been added.

Join our Companion Diagnostic Lead, Rolf Thermann, as he speaks at the Next Generation Dx Summit about Advancing Novel Frameworks for Companion Diagnostics in Europe. The 16th Annual Summit will take place from August 19-21, 2024 in Washington, D.C. and virtually.

📣 Regulatory Update: MDCG 2020-16 Rev. 3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. What has changed with revision 3? The third revision introduces several clarifications to rules 4(a) and 5(c). Under rule 4(a), the revision introduces a provision stating that devices intended for testing services offered to laypersons, including those via information society services, are considered self-testing devices if the layperson performs part of the testing procedure, such as adding a reagent or placing a specimen on a test cassette. Standalone specimen receptacles and kits intended for specimen collection, when intended to be used by lay persons for specimen collection only, are not considered devices for self-testing (see rule 5). Devices for measuring calprotectin levels where the layperson collects the stool specimen and uses a test cassette are Class C, while self-testing kits for detecting HIV antibodies from a finger-prick blood sample are Class D. This new revision also provides more details on the rationale and examples under rule 5(c). For example, the revision discusses cases where specimen receptacles and kits intended for specimen collection are placed on the market and intended to be used in combination with another IVD. In this case implementing rule 1.2 applies: the specimen receptacle or kit intended for specimen collection and the other IVD should be classified independently. When a specimen receptacle or a kit intended for specimen collection is a component of a kit in which the lay person not only collects the specimen but also performs one or more actions that are part of the testing procedure, the whole kit is considered a device for self-testing (see rule 4). As components of the kit intended for testing, the specimen receptacle or specimen collection kit may be CE-marked and classified in their own right according to their intended purpose and would not themselves be considered devices for self-testing. Consequently, the list of examples of collection cups, containers and tubes was revised. Other revisions include changing the example for detecting Influenza A/B virus from "non-pandemic" to "not highly virulent" (rule 6) and adding "kit" under Definitions.

📣 Regulatory Update: MDCG 2024-10 Clinical evaluation of orphan medical devices   Orphan medical devices are defined in the new guidance as device intended for rare conditions affecting fewer than 12,000 people in the EU annually. The guidance outlines criteria for a device to qualify as an orphan device, emphasizing the lack of alternative treatments and expected clinical benefits.   The Medical Device Regulation (MDR) in the EU has high requirements for the clinical evidence for in particular high risk devices, making it difficult for manufacturers to maintain orphan devices in the market, or market new devices. For such devices, there is a challenge to generate sufficient pre-market clinical evidence due to their limited patient populations. The Medical Device Coordination Group (MDCG) acknowledges these challenges and suggests a balanced approach to MDR requirements for orphan devices, ensuring patient access without compromising safety. While requiring sufficient clinical evidence is important to ensure the safety of patients, also the potential absence of devices in the market that are required to treat rare diseases or vulnerable patient collectives as infants and children has ethical implications. As consequence, there is a need to balance the need for clinical evidence with the practicalities of developing treatments for rare conditions. As an example, a device used in pediatric heart surgery can save the life of neonates, however a randomized controlled clinical trial on several hundreds of patients as would normally be expected for such type of high-risk device may be not feasible to conduct in the pre-market phase.   The MDCG's guidance document, MDCG 2024-10, offers advice on clinical evaluation and procedural considerations for orphan devices. It allows for market access with limited pre-market data, provided that there is transparency about the device's limitations and a robust PMS and PMCF plan to gather further data.   For manufacturers, demonstrating an orphan device's status involves providing epidemiological evidence and justifying the device's clinical benefit over existing alternatives. Notified bodies play a crucial role in assessing orphan devices, potentially setting specific conditions for certification, and ensuring ongoing post-market surveillance with specific methods for PMCF. The expert panels organized by EMA/Expamed offer advice on orphan device status and clinical data requirements, contributing to the decision-making process for market access.   In summary, the MDCG's guidance aims to support the availability of orphan devices while maintaining patient safety and upholding regulatory standards.

Ever wondered how we ensure patient monitors are reliable? Tóth Szabolcs published a new article on diving into the world of multifunction patient monitoring equipment testing. Key points covered: 🔹 What these devices actually monitor 🔹 The critical standard EN IEC 80601-2-49:2019 🔹 5 key aspects of testing Whether you're in healthcare, medical device manufacturing, or just curious about the tech keeping patients safe, this post is for you! Check it out and join the discussion. Florian Staudigel Kelly Bertrand, PMP Dr Nicholas T. Kirkland Mohammed (Simo) Dkhissi #PatientSafety #MedicalDevices #HealthcareTech

The EU AI Act has been published in the EU Official Journal on July 12th, marking its official release and entry into force on August 1st, 2024. Discover the timeline and learn when the Act will be enforced for medical devices.   #EUAIAct #MedicalDevices