The strategy is crucial for the success of a company because a product can only be brought to market if all regulatory requirements are met. Our team of medical device regulatory affairs and quality management system (QMS) consulting experts will start with a gap analysis of your QMS, Technical Documentation, and Clinical Evaluation documentation. You need a partner equipped with the right tools and know-how to help you translate the regulatory requirements for your QMS and establish the interlinkages necessary among core processes. Regulatory considerations are therefore crucial for the success of a business. Manufacturers are expected to revisit their core QMS processes, such as risk management and post-market activities, to ensure they are aligned with the new regulations and interlinked to other processes in their system. Clinical Evaluation requirements have increased dramatically since the release of MEDDEV 2.7.1 Rev 4 in 2016 and the MDR 2017/745 in May of 2017. Or request a demo to talk with one of our team members. In addition to commercial decision criteria, such as revenue and market share, regulatory requirements are also decisively important. The regulatory pathway is the core of your regulatory strategy. Often, manufacturers utilize their internal team to plan and implement the additional QMS requirements, leaving them without fully independent auditing. The processes needed to make the technical documentation stay up to date for the lifetime of the device. How Can Companies Train for EU MDR Changes? %PDF-1.6
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Enter your email address and someone will contact you shortly to provide more Clinical Investigator data about your sites. The MDR describes a detailed regulatory environment that outlines rules and regulations for all aspects of developing, marketing and monitoring the performance of medical devices. Successful compliance is demonstrated by the application of a CE-mark to the device. Analyzing PMS data to compile the required reports, Establishing an EU MDR audit plan that integrates into the current internal auditing plans, Training internal auditor teams on techniques to audit against the MDR, Following up and assist in implementing corrective actions to address nonconformities. We use cookies to optimize your user experience. Lean into quality with medical device systems everyone can trust. Please note that the MDR compliance process is essentially the same for physical medical devices and any digital products that meet the definition of Software as a Medical Device (SaMD). Medical devices must be designed, manufactured, distributed and tracked according to EU MDR requirements, and manufacturers must develop a suite of compliant regulatory systems, processes and documents to continually monitor the safety and performance of their products. Even though some markets are well known for high-profit margins in general, it is vital to make this decision based on your product and perceived market demands; some markets are more attractive for a specific product than others. with our social media, advertising and analytics partners. FY2018-FY2020 GMP data for Lonza & Catalent, Featuring Panelists: Barbara W. Unger, Unger Consulting, Inc.Jerry Chapman, Redica SystemsStephanie Gaulding, Pharmatech Associates. For example, a Quality System Certification to ISO 134585:2016 is a basis for approval in other countries such as Canada and Australia. In particular, the approach differs in the classification of medical standalone software i.e. Phone: 512-328-9404 It establishes the corresponding requirements in Annex III, making the technical documentation a living document throughout the lifetime of the device. It is therefore essential that medical device manufacturers develop a detailed understanding of the MDR or risk falling short of requirements. As of May 26, 2021, manufacturers should have already started complying with the EU MDR, at least for the transitional provisions requirements of Article 120(3) for devices placed on the market today with a valid CE certificate under the Directives. Contact QA Consulting to assist you with the following services: Contact QA Consulting to assist you with performing baseline gap analyses for the following areas: Contact QA Consulting to assist in closing the gaps in your QMS by establishing and/or updating processes for the following areas: The technical documentation must include: Contact QA Consulting to assist you with the following services in compiling your technical documentation: Contact QA Consulting to assist you with the following services in compiling your clinical evaluation documentation: Contact QA Consulting for the following services to assist you in setting up your PMS system: Contact QA Consulting to assist with audit services that align with the new regulations, including: EU MDR Transition Timeline and Regulatory Strategy, Sign-Up for Our Device Discourse Newsletter, Determining the conformity assessment route suitable for your organization and devices, Documenting a strategy for the regulatory requirements for entry of your medical device to the EU market, Establishing an agreement with the authorized representative, importer and distributor(s), Identifying a person(s) that meet the qualification criteria for the Person Responsible for Regulatory Compliance (PRRC) per Article 15, Performing a baseline gap assessment of the MDD technical files, CERs, and QMS against the MDR, Authoring an EU MDR transition quality plan, Implementing solutions to address identified gaps, Preparing and/or upgrading clinical evaluation documentation, Preparing and/or upgrading technical documentation, Expertise and training needed to mature to the understanding in implementing the new EU regulations, Person Responsible for Regulatory Compliance (PRRC), Change control and reporting requirements, Vigilance, trend reporting and Field Safety Corrective Action (FSCA), Identification of the device (e.g., with a UDI), Description of the device, including variants, configuration, and accessories, Labeling (packaging, instructions for use, etc. Drafting the technical documentation to Annex II requirements, Generating the Clinical Evaluation Documentation (CEP, CDP, and CER), Establishing the QMS procedure and templates necessary to author the, Clinical Evaluation Documentation to the new regulations, Establishing a Clinical and Regulatory Strategy, Conducting gap analyses of existing clinical evaluation documentation, Assessing and providing guidance on clinical and performance claims, Assessing and providing guidance on equivalency claims, Assessing and providing guidance on the quality of available clinical data, Authoring the Clinical Development Plan (CDP), Authoring the Clinical Evaluation Plan (CEP), Establishing and executing a Literature Search Protocol (LSP), Authoring the Clinical Evaluation Report (CER), Establishing PMS and PMCF procedures and associated plans and reports templates, Training your organization on the PMS and PMCF requirements, Authoring PMS and PMCF plans tailored to the risk of your devices, Assisting the organization in conducting serious incident reporting and Field Safety Corrective Action (FSCA). What are the main regulatory differences for medical devices between the US and EU? It should be clear that designing Clinical Investigations intended to be part of any MDR compliance strategy is a specialist task that requires extensive clinical, regulatory, legal and medical device industry experience. Z|/2.tK}*t\?
ugTkd}4\"~[ The most effective route to achieving EU MDR compliance has two distinct phases: Developing a deep understanding of the regulatory framework is a crucial first step in achieving MDR compliance. By continuing to use our site you agree to
A thorough understanding of the MDR allows you to apply this knowledge, along with guidance from harmonised standards and MedDev guidelines, to begin constructing MDR-compliant systems and processes. Let us know who you are and well be in touch to answer all of your questions and get you started. Also, certain processes required to maintain compliance might apply in the EU and not in the US. The level of evidence required to prove safety and performance of the device (e.g. Whereas both US and EU require a local representative when the manufacturer is based outside the jurisdiction, the role and duties of the US Agent vs. the EU Authorized Representative (EAR) differ significantly. Many regulatory processes that are required for MDR Compliance follow the same cyclical structure for their implementation and maintenance which should be reflected in their design. Presented by Steve Greer on June 23, 2020, The first countrywide import alert issued by FDA, An inadequate product specifications and a product recall, A different perspective on process validation and the culpability of the quality unit, How a major pharmaceutical company designed a program to train future leaders in quality, An industry-led initiative to advance the state of quality in the pharma industry, A pharma GMP leaders tips for supporting quality culture within an organization, An update on FDAs Quality Maturity Model, Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020, Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp, The latest U.S. and European regulatory developments, How the EU MDR impacts drug-device combination products. Redica Systems Senior GMP Quality Expert Jerry Chapman moderated. In addition, the EU MDR has highlighted more specific requirements and items that must be present to be in compliance. These changes require discussion among the cross-functional teams involved in key roles to minimize duplication of work and ensure consistency across documentation. Your regulatory strategy is intertwined with your marketing strategy, as gaining access to markets is preceded by regulatory approval. Class I devices that are sterile or that have a measuring function must seek approval from a Notified Body. In this comprehensive free guide, written by our experienced experts, we outline essential requirements in detail and cover all aspects of the medical device regulatory framework. The need to evidence every indication is placing huge demands on evidence-generation systems that will need to be expanded or re-designed in order to meet needs. STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data. ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations. In brief, your regulatory strategy for a medical device to be launched in the US and EU needs to account for potentially significant regulatory differences in: device qualification, device classification, compliance requirements, and compliance ownership. Although generally robust and relatively permissive of innovation, the MDD was considered to have numerous flaws in enforcing medical device safety, reliability and general product quality, exposed by notorious incidents such as the metal-on-metal hip scandal. The MDR goes one step further: It includes post-market surveillance under technical documentation with its planning and implementation.
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