Strengthen Datasets Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.
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. Devices must be developed within an appropriate Quality Management System (QMS), with most manufacturers applying ISO 13485:2016 as a harmonised standard to ensure QMS suitability. clinical data, absence of certain chemicals) might be higher in the EU than in the US for the same medical device. How companies can avoid similar shortcomings. INDEX INFORMATION Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence. The purpose of the post-market surveillance system is to systematically and proactively collect, record, and analyze data essential for the quality, performance, and safety of the appliance throughout its shelf-life and to update the risk-benefit assessment. Bldg 1, Ste. Class I devices that are sterile or that have a measuring function must seek approval from a Notified Body. 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. The requirements for the device are defined in Annex I and the requirements for the documentation in Annex II. 
We also explain who can sell medical devices in the EU and the US and how the requirements for economic operators differ. EU MDR compliance begins with a detailed understanding of the regulation and the obligations it imposes upon manufacturers. This also includes information on distribution channels (e.g. How Can Companies Train for EU MDR Changes?
The new MDR attempts to reduce the likelihood of future incidents of this nature by enhancing requirements for proving safety and effectiveness of all medical devices, regardless of how long the product has been on the market. Special caution is recommended for devices intended to administer drugs, since drug-device combination products are regulated under a single set of rules in the US and overseen by a single competent authority whereas they are subject to dual legislation in the EU. 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. Your regulatory strategy is intertwined with your marketing strategy, as gaining access to markets is preceded by regulatory approval. Even with a thorough understanding of the MDR, building compliant systems can be challenging. (E]A*/V7M.y9Y1)E[}f|&F|W\c>j~(49L.hCb n_z^BIN_NM"Jvu:.X4Orv`f&_]'q!G@Ot;+i]%^KJKI[,|R&uU|_8i_|`e5,ac9_rynh]G8/:_LEeSVSXa. The Medical Device Regulation MDR 2017/745, commonly known as the MDR, is an extensive piece of legislation that represents the largest overhaul of medical device regulation in decades. QA Consulting, Inc. Class I manufacturers (except for devices that are sterile or have a measuring function) may self-apply a CE-mark after producing a declaration of conformity. The cost and complexity of MDR compliance are a challenge. STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data. It may seem obvious but it tends to be overlooked: the US is a country, whereas the EU is the political and economic union of 27 European countries (EU Member States).
The US has a definite set of federal legislation on medical devices (in the US Code, USC, and Code of Federal Regulations, CFR), a single competent authority (US FDA), and a single language required for medical device labelling (English). 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). These changes require discussion among the cross-functional teams involved in key roles to minimize duplication of work and ensure consistency across documentation. In addition, there are other regulatory-related factors we suggest to consider when planning the market entry, for example: Gaining market approval requires effort. The new regulations expect implementation of the requirements and maturity in understanding how these new requirements are necessary to place safe medical devices in the EU market for EU citizens. For all other classes of medical device, a CE-mark may only be affixed once a Notified Body has issued a certificate of conformity following a regulatory review according to rules in Chapter IV of the MDR. If you are looking for assistance in any step of the most appropriate regulatory strategy for your medical device, here is how Decomplix can help. This is the last date for placing medical devices on the market unless they meet MDR requirements. The EU Medical Device Regulation (EU MDR) became effective in May 2021. Those familiar with the EUs medical device QMS standard, EN ISO 13485:2016, should immediately recognize similarities with Article 10 and Annex IX. The MDR (2017/745), which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has come to fruition. Analyze & Interpret Patterns Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations. What aspects to consider in your regulatory strategy? Video 1: A 3 minute summary of EU MDR compliance. In it, we explain the differences in the definition and qualification of medical devices and the assignment of the regulatory procedure based on the risk class. Ensuring that product development meets all regulatory requirements is essential to meet manufacturers competitive challenges. Despite the deadline, many medical device manufacturers have yet to prepare for compliance with these new requirements or organize their regulatory transition strategies. Get quality and compliance insights from our experts in your inbox. 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. Quality System Certification to ISO 134585:2016, Introduction to medical device regulatory strategy, Your regulatory strategy drives your marketing strategy. In almost all markets worldwide, the risk classification determines the regulatory pathway and, therefore, the level of regulatory scrutiny that applies to your device. 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. Legislators were compelled to implement reform. A complete starter guide to get ready for the EU MDR. Video 2: How to build an EU MDR compliance strategy for your medical devices. Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform. Mantra Systems Ltd - Medical Device Regulatory Consulting, Work through our free guide, access our online resources & learn strategies for EU MDR Compliance. Anyone who develops and wants to sell a medical device must make a careful decision about the target markets. They will then guide you through the implementation of EU MDR requirements to ensure your organization is compliant with the EU MDR, audit-ready, and can successfully place devices in the EU market. Enter your email address and someone will contact you shortly to customize your report. There are several factors to consider when deciding which market to enter with a medical device. Read more in Part II of this blog post. Clinical Investigations must minimise the potential for bias, be adequately powered, represent the population normally subject to the device, and employ appropriate methods of statistical analysis in interpreting and applying results. As a result, many medical device manufacturers may have questions as they adjust their regulatory compliance strategies, particularly for products marketed to in the European Union. However, each of them has its own legislation, competent authority, and mandatory labelling language(s). This highlights both the low level of understanding and the low level of preparedness towards regulatory compliance within the industry. 250 Complete the form and one of our experts will reach out to you to schedule a demo and answer questions about our subscription options. To classify your device, you need to have defined its intended purpose and intended user as well as a comprehensive list of device functions. SaMD (software as medical device) in US and MDSW (medical device software) in EU. EU MDR Consulting Services for all classes of medical devices. Incident reporting and surveillance of medical devices identify problems with the design, manufacture, final inspection or use of the device, and increases patient safety. Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds. These countries have adopted CE marking as the mutually recognized conformity assessment process for medical devices. Achieving marketing capital often depends upon a robust and well-built regulatory strategy.
This also includes information on distribution channels (e.g.
If you have any questions about the information in this guide please talk with a member of our team. The MDR introduces a range of changes that place a higher burden on manufacturers in many areas, including: It is also important to keep updated with harmonised standards such as ISO standards, compliance with which will lead to a presumption of compliance with the MDR in that area. 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. Although the MDR is not yet in full force, many manufacturers from all sectors of the industry are facing challenges in meeting the requirements for EU MDR compliance. Therefore, a regulatory strategy can only be developed once the initial phase of product development is completed. Years in the making, the European Union has now transitioned from the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) to the European Medical Device Regulation (MDR) (2017/745). EFTA countries, Turkey, and European microstates like Andorra, Monaco and San Marino). It is not enough simply to produce clinical evidence; the methods by which such evidence is generated must also be compliant with requirements. Clinical evidence includes that generated and held by the manufacturer, as well as data published independently in journals and other sources.
The attractiveness of a market needs to be weighed with regulatory requirements in mind as the time, cost, and complexity of getting and maintaining a medical device approval cannot be underestimated. For example, demonstrating conformity to the GSPRs, developing PMCF procedures within a PMS system, and performing Clinical Evaluation may all involve the design, documentation, implementation, conduct and interpretation of clinical investigations. It is therefore essential that medical device manufacturers develop a detailed understanding of the MDR or risk falling short of requirements. The first step consists of identifying the key target markets and evaluating the overall scale of the effort to gain market access through regulatory approval. We can help simplify and guide your compliance operations with advanced data analytics.
Redica Systems Senior GMP Quality Expert Jerry Chapman moderated. Manufacturers will also need to generate and provide more in-depth clinical data to prove safety and performance claims, including tighter equivalency standards. 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. distance sales, restrictions on dispensation of medical devices subject to prescription), reimbursement policies, and similar devices on the market (which would reduce the level of novelty of your device and might simplify the proof of evidence needed for approval). Lean into quality with medical device systems everyone can trust. By contrast, most Class I devices do not normally require involvement of a Notified Body but must still be supported by MDR-compliant regulatory files, systems and processes. Enter your email address and someone will contact you shortly to run your custom report. Meeting the requirements of the MDR in time will require many manufacturers to implement new policies and strategies well ahead of the deadline. 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. The regulatory pathway is the core of your regulatory strategy. tools, Two case studies, one on sterile manufacturing/503B and one on data integrity, Data Integrity Observations for Human Drugs, Human factors strategies from simple drug products to complex surgical devices, Primary and secondary labeling development and evaluation for usability, Human factors activities from product development to post-market, International strategies: expectations for human factors in regulatory submissions in international markets. In order to support your strategic decisions, the basic regulatory requirements in the EU and the US, as well as the main differences, are outlined in the following paragraphs. Five FDA Warning Letters Issued in Four Years for Fraudulent Cancer Drug, Invest in Tech to Avoid Data Integrity Issues, A comparison of 483 observations in FY2019, Top 10 Russian Ministry of Health inspection findings, Trend analysis of FDA inspections through mid-2020, Strategies for preparing and hosting virtual inspections, New technologies to support remote inspections, How to use the Leadership SOS Model to transform quality culture, How to strengthen quality systems to eliminate human error, How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff, Trends from 2015, 2016, 2018, and 2019 inspections, Conclusions drawn from an analysis of drug inspection data, The 3C Model to become a champion of change, How to identify game-changing habits and the steps to implement them, Ways to develop greater purpose-centered leadership, How to generate awareness along with actions to create changes in how you think about challenges and change putting you on a path to lead change successfully in your organization, Examples of essential laboratory actions to remain compliant during the pandemic, Recent data integrity non-compliance findings and trends, Essential strategies to find, understand, and leverage regulatory non-compliance data, The latest developments regarding the EU MDR, Quality Systems requirements for medical devices, Regulatory updates affecting medical devices, A basic understanding of data sources, machine learning, NLP, and A.I. How the 2014 FDA quality metrics initiative led to greater focus on quality culture, New quality culture tools and standards under development by PDA and other organizations, Best practices for quality culture, including case studies with lessons learned, The EU MDR and What it Means for Your QMS, Global Harmonization of EU MDR Requirements. 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. Austin, TX 78735 Time is of the essence, but it is precisely this factor that is difficult to control and often the effort and complexity of obtaining and maintaining approval or certification of a medical device is underestimated. Free PDF download Even more important is the different definition of manufacturer in both jurisdictions and the fact that a US distributor selling a device under its name or co-packaging several devices might be viewed as the manufacturer in the EU, and be responsible for CE marking. The MDR not only impacts your technical documentation but the entire Quality Management System (QMS). Those required for MDR Compliance include the following: Rules for assessing compliance differ according to the risk class of the device. In addition, the various MedDev guidelines provide guidance in structuring and performing a range of MDR Compliance activities. Most of a manufacturers Quality Management System (QMS) requirements are contained in Article 10 and Annex IX of the MDR. However, requirements may also be found in other articles and annexes that may not be immediately obvious. The new regulations take many resources to implement. using cookies in accordance with our Privacy Policy. Enter your email address and someone will contact you shortly to get the data and analysis you need. This requires a detailed understanding of the regulatory framework as well as a well-constructed strategy plan, which defines the appropriate requirements, activities, and responsibilities. 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. distance sales, restrictions on dispensation of medical devices subject to prescription), reimbursement policies, and similar devices on the market (which would reduce the level of novelty of your device and might simplify the proof of evidence needed for approval). The MDR goes one step further: It includes post-market surveillance under technical documentation with its planning and implementation. Many companies will fail to produce clinical evidence of the standard required because they do not have access to such expertise in-house, threatening the regulatory approval status of their products. Phone: 512-328-9404 Also, certain processes required to maintain compliance might apply in the EU and not in the US. 201 0 obj <>stream Annex XV MDR determines that necessary documentation includes a Clinical Investigation Plan and Investigators Brochure for each Clinical Investigation, as well as any other information deemed necessary to ensure proper conduct of the study and scientific validity of results. Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble. The text of the MDR contains the basis for the rules that regulators will apply when assessing every medical device submission. 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. Those requirements are primarily found in Article 10 and Annex IX. 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. Presented by Jerry Chapman on October 29, 2020. Clinical evidence has assumed an even greater level of importance in demonstrating device safety and performance under the MDR than it did under the MDD. 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. 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. info@qaconsultinginc.com, QA Consulting, Inc. All Rights Reserved.Privacy Policy | Terms & Conditions. You can find more basic information on the regulatory requirements in the EU and the US in the second part of the blog post. Clinical evidence must be produced and identified in relation to all medical devices under the EU MDR. These articles are valuable for anyone wishing to learn more about the EU MDR and to further refine their regulatory compliance strategy. Learn more about our Medical Device Regulatory Consulting Services. In particular, generating clinical evidence draws upon a deep understanding of clinical investigation design and medical insight. 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. To anticipate the time, cost, and complexity of getting your device approved in a particular market, you (obviously) need to know the regulatory requirements applicable to your device. The same product might fall under the definition of medical device in the US and not in the EU, where it might correspond to a cosmetic, pharmaceutical, consumer product, or another regulatory category. Who Will Benefit?This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.
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