Where there are They must not compromise the health or safety of a patient, user, or any other person associated with the device. EU MDR Checklist: Overview Our regulatory experts have worked through the regulations, picking up the most minute compliance points and developing them into a 23-page checklist of actionable technical documentation requirements that you can use to ensure that you are meeting all EU device manufacturing mandates. Subject: 'Exhaustive' Checklist: How To Comply With The EU MDR, Including For UDI And Clinical Data Add a personalized message to your email. This measure is to reduce the burdens on the healthcare systems. We help you in the process of making a defined and comprehensive technical file with all product details required for CE marking. The EU MDR Compliance Checklist: Tracking Progress to Date. Our guide is simple to understand and will allow you to save time and money when implementing the new regulation. Medical Device Registration in South Africa, Medical Device Registration in Saudi Arabia. MDR Documentation Submissions – Revision 2, May 2020 Page 3 of 41 . EU MDR checklist We’ll help you for the process of making a defined technical file with all the product details. A thorough gap analysis will generate a task list for updating your procedures and documentation. The general requirements for each overlap with each other and consist of the following: By early 2020, medical device companies should have completed several tasks to meet the May 26 deadline: Product Scoping: A wider range of products are in scope of the MDR when compared with the Medical Device Directive (MDD) it replaced. But the new Medical Device Regulation (2017/745) is a mass of new requirements. Check if your EU MDR implementation is on the right track. If you haven't heard, MDR is replacing EU MDD (993/42/EEC) as well as the EU's directive regarding active implementable medical devices (90/385/EEC). To prepare for the new EU MDR checklist, many medical device manufacturers are in the process of conducting gap evaluations and creating EU MDR transition action plans. There are also 22 rules outlined in the regulation’s legal text to determine an in-scope product’s classification, which informs reporting responsibilities. GSPR Checklist was carefully prepared by our experts to help you comply with the General Safety and Performance Requirements listed in Annex I of the MDR 2017/745. These technical files are then sent to notified bodies, which certify the product. EU MDR & EU IVDR Checklist. Device manufacturers must implement and maintain a thorough, well-documented, and evaluative risk management system that continues to be updated throughout the life cycle of a device. This process should ideally have begun shortly after the announcement of the EU MDR in 2017. With May 2020 around the corner, we understand that a clear understanding of the most critical items to address is crucial and have compiled an EU MDR checklist with actionable technical documentation requirements. document.write(new Date().getFullYear()) Devices must be designed, manufactured, and packaged in a way that protects them from damage during transport and storage. This information must be clear, easy to understand, and considerate of the users’ technical knowledge level, use environment, and any applicable medical conditions. Cancel. Your first step should be to assess your current level of compliance. Advisera Expert Solutions Ltd. Get an overview of all the required documents. Using a cloud-based platform solution such as the Assent Compliance Platform helps companies gather and manage this data effectively. All medical devices will need to comply, where applicable, with these requirements. Transitioning to the MDR might seem overwhelming, and many companies don’t know where to start. For example, new criteria in the MDR bring a variety of products and devices without a specific medical purpose into scope, including lotion or gel dispensers, colored contact lenses and throat lozenges. 2 | EU MDR executive summary KMPG’s broad expertise makes it a valuable partner for EU-MDR compliance The KPMG Team offers the following set of EU MDR related services to meet your compliance needs Manufacturing — UDI impact assessment — GS1/GTIN education — Packaging line changes Supply Chain — Economic operator remediation Class I; Class IIa; Class IIb; Class III; This goes from the products with low risk (Class I) to the products with high risk (Class III). Check if your EU MDR implementation is on the right track. See how EU MDD and MDR compare, what is the transition period, and what are the main similarities and differences you should be aware of. 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