EU MDR Regulatory Strategy
EU MDR Transition Timeline and Regulatory Strategy
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).
The new regulation introduces major changes to how medical device manufacturers obtain CE Marking and maintain access to the European market. Despite the deadline, many medical device manufacturers have yet to prepare for compliance with these new requirements or organize their regulatory transition strategies.
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.
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. 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.
QA Consulting offers customized EU MDR services for the following:
- EU Market Regulatory Strategy
- Baseline Gap Analyses
- QMS Remediation
- Technical Documentation
- Clinical Evaluation
- Post-Market Surveillance
- Internal Auditing
EU Market Regulatory Strategy
In order to place a new product on the market within the EU, there are several requirements to be met as defined in the EU Medical Device Regulation. The detailed requirements apply beginning with the design stage, through production, quality control, and product registration.
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. A manufacturer’s transition date is dependent on the date of their CE mark. May 26, 2024, is the date certificates issued under MDD become void. This is the last date for placing medical devices on the market unless they meet MDR requirements.
- Classification of your medical device(s)
- 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
- EUDAMED registrations
Baseline Gap Analyses
The MDR not only impacts your technical documentation but the entire Quality Management System (QMS). The processes needed to make the technical documentation stay up to date for the lifetime of the device.
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.
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.
- Quality Management System (QMS)
- Technical Documentation
- Clinical Evaluation Report Documentation
- Linkages among core processes
- Expertise and training needed to mature to the understanding in implementing the new EU regulations
Most of a manufacturer’s Quality Management System (QMS) requirements are contained in Article 10 and Annex IX of the MDR.
Those familiar with the EU’s medical device QMS standard, EN ISO 13485:2016, should immediately recognize similarities with Article 10 and Annex IX.
In addition, the EU MDR has highlighted more specific requirements and items that must be present to be in compliance. Those requirements are primarily found in Article 10 and Annex IX. However, requirements may also be found in other articles and annexes that may not be immediately obvious.
The cost and complexity of MDR compliance are a challenge. 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.
- Strategy for regulatory compliance
- Person Responsible for Regulatory Compliance (PRRC)
- Design and development
- Control of documents
- Change control and reporting requirements
- Risk management
- Clinical Evaluation Report
- Technical documentation
- Post-market surveillance (PMS)
- Post-Market Clinical Follow up (PMCF)
- Vigilance, trend reporting and Field Safety Corrective Action (FSCA)
- Management of Economic Operators
- Purchasing and supplier management
- Management of hazardous substance
- Unique Device Identification (UDI)
- Internal audits
- Communication and more QMS
The requirements for the device are defined in Annex I and the requirements for the documentation in Annex II.
- Identification of the device (e.g., with a UDI)
- Description of the device, including variants, configuration, and accessories
- Intended use
- Labeling (packaging, instructions for use, etc.)
- Information on the design and manufacture of the device
- Risk management file
- Clinical evaluation report
- Verification and validation of the device and, therefore, proof that the device meets the general safety and performance requirements
The MDR goes one step further: It includes post-market surveillance under technical documentation with its planning and implementation. It establishes the corresponding requirements in Annex III, making the technical documentation a living document throughout the lifetime of the device.
- Establishing the QMS procedure and templates necessary to author the technical documentation to the new regulations
- Conducting gap analyses of existing technical files/design dossiers
- Determining the applicable General Safety and Performance Requirements (GSPRs)
- Determining the methods to implement the applicable GSPRs and conducting verification, validation, technical rationale, etc.
- Drafting the technical documentation to Annex II requirements
- Generating the Clinical Evaluation Documentation (CEP, CDP, and CER)
- Generating the PMS and PMCF plans
- Drafting the Declaration of Conformity
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.
The new regulations emphasize the link between the design and development process, post-market surveillance, and risk management, with consistency between all documentation required.
These changes require discussion among the cross-functional teams involved in key roles to minimize duplication of work and ensure consistency across documentation.
Manufacturers will also need to generate and provide more in-depth clinical data to prove safety and performance claims, including tighter equivalency standards.
- 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)
Post-Market Surveillance (PMS)
Article 2 of the MDR defines post-market surveillance (PMS) as “all activities carried out by manufacturers in cooperation with other economic operators to establish and update systematic procedures for the proactive collection and review of experience gained from devices they place on the market, make available on the market or put into service, which are carried out in order to identify the need for any necessary corrective or preventive action immediately.”
Incident reporting and surveillance of medical devices identify problems with the design, manufacture, final inspection or use of the device, and increases patient safety.
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.
As of May 26, 2021, manufacturers must collect and assess PMS information about their medical devices and similar medical devices placed in the EU Market.
- 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)
- Identifying root cause for issues identifying and establishing corrective actions to be taken.
- Analyzing PMS data to compile the required reports
The new regulations take many resources to implement. Often, manufacturers utilize their internal team to plan and implement the additional QMS requirements, leaving them without fully independent auditing.
Therefore, conducting an audit led by independent experts enables companies to diagnose the condition of the implemented quality management system and assess what actions should be taken to ensure full compliance.
- Establishing an EU MDR audit plan that integrates into the current internal auditing plans
- Conducting internal or mock audits
- Training internal auditor teams on techniques to audit against the MDR
- Issuing audit reports
- Following up and assist in implementing corrective actions to address nonconformities