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Is your QMS (Quality Management System) ready to help you comply with the new EU MDR regulations for medical devices? The implementation of the EU MDR on May 26, 2021 has brought about a huge change in medical device regulations in the European Union. This is to be followed by the EU IVDR for IVD devices which becomes effective from May 26, 2022.

In this blog, we help you understand the new requirements of EU MDR & EU IVDR and the specific steps you need to take to become compliant.

Understanding QMS Needs Under EU MDR and EU IVDR

The new EU MDR promotes a life-cycle approach to medical device regulation and is more focused on the pre-approval stage of medical device manufacturing.

IVDR (the in-vitro diagnostic device regulation) incorporates new requirements for risk classification, clinical evidence, and conformity evaluation procedures that need to be managed within the manufacturer’s QMS.

Another QMS requirement of the IVDR is post-market surveillance procedures and activities. You can track and collect feedback from users with a feedback loop system for reverting and updating your risk management file complying with these requirements. Thus, you can efficiently monitor the overall device performance.

Wondering which steps to focus on and prioritize during the EU-MDR certification process? Would you like to automate the process of coordinating with the Notified Body (NB)?

Listen to this webinar to find out: how companies around the world are navigating the challenges of EU-MDR Certification requirements.

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The QMS requirements in the new EU MDR and EU IVDR include:

  • Compliance with conformity evaluation procedures
  • Identification of general safety and performance requirements
  • Resource management, including selection and control of suppliers and subcontractors
  • Risk management and clinical evaluation including post-market surveillance follow-up (PMPF)
  • Product realization, including planning, design, development, production, and service delivery
  • Verification of the UDI assignments with Article 27(3) to all relevant devices
  • Ensuring consistency and validity of the information provided with Article 29
  • Assessment, implementation, and maintenance of a post-market surveillance system with Article 83;
  • Managing communication with notified bodies, competent authorities, other economic operators, customers, and other stakeholders
  • Reporting serious incidents and field safety corrective actions
  • Management of CAPA actions and verification of their efficiency
  • Processes for tracking and measurement of output, data analysis, and product improvement

Start planning by conducting a gap analysis

Assess your preparedness to meet the new regulations as well as ISO 13485:2016 requirements and identify if there are any gaps in your systems and processes.

Get in touch with a Notified Body (NB) as soon as possible to plan your upcoming audits. Many NBs are asking manufacturers for key information that can be introduced in the technical documentation to conduct timely audits with ease.

Existing NBs are re-certified under the EU MDR to ensure the safety and effectiveness of medical device products. NBs have to be established under the national laws of the respective member states or laws of the respective country. To become nominated under EU MDR, NBs have submitted applications to the authorities in November 2017. Joint audits were performed by the European Commission in April 2018. BSI was the first NB nominated under EU MDR in January 2019.

As of June 21, 2021,

  • 20 NBs are designated under MDR
  • 5 NBs are designated under IVDR

EU MDR implementation or transition can face challenges due to the designated NB not having enough qualified or expert reviewers. In such a case, they will seek external experts for technical documentation reviews.

Some of the other challenges can be about whether the clinical investigation study, though complete, is adequate under the EU MDR. It will also be critical to ensure that schedules and timelines are aligned between the qualified reviewers, expert reviewers, technical documentation application, and the QMS and mitigation plans are discussed upfront during the planning stages.

Post-Market Surveillance requirements under MDR & IVDR

The post-market surveillance (PMS) requirement is one of the major changes under the MDR and IVDR guidelines. You need a PMS plan for consistent updates to your technical file, clinical evaluation report, and risk management file. The QMS can largely mitigate the risk of human error and eliminate costly rework by making all these updates. ComplianceQuest’s QMS enables manufacturers to obtain more visibility of all connections, execute changes, and understand the impact of those updates on your quality system — ideally by using a next-generation EQMS with data and AI capabilities.

Electronic system of economic operators for registration (Article 30)

EUDAMED (European database for medical devices), is an IT system developed by the European commission to implement the medical device regulation for medical devices. It was intended to be used for registration, collaboration, notification, and dissemination of device information to improve transparency regarding medical devices available in the market.

There are six interconnected modules of EUDAMED implementation:

1. Single registration number:
Registration of different actors who entered pertinent information including the PRRC

  • Supervising bodies: competent authorities, notified bodies and EC,
  • Economic operators: MAID (manufacturer, authorized representative, importer, and distributor)
  • Sponsors of clinical investigations

The timeline for implementation: December 2020.

2. UDI registration: registration of medical devices enables manufacturers to enter or update core UDI information and register legacy devices, usage of EMDN nomenclature.

The timeline for implementation: September 2021

3. NBs and certificates: provide information on certificates issued by NBs, communication between NBs on application withdrawals, status on clinical evaluation, summaries of safety and clinical performance, and assessment reports.

The timeline for implementation: September 2021

4. Performance studies and clinical investigations: management of clinical investigation or performance evaluation data, applications, notification of post-market clinical follow-up, notification and submission of changes and reports etc.

The timeline for implementation: May 2022

5. Post-market surveillance and vigilance: automatically submit PSUR, trend reports, reporting serious incidents, FSCA and FSNs and distribute to all competent authorities.

The timeline for implementation: May 2022

6. Market surveillance: enable coordination and cooperation between the member states, competent authorities, notified bodies, summary reports on market surveillance activities made available to the public.

The timeline for implementation: May 2022

You should take a proactive approach and monitor the European Commission website. Also, follow interim QMS procedures in the absence of EUDAMED.

SOP updates in the QMS to meet MDR & IVDR requirements

There are some updates needed in terms of standard operating procedures and processes to meet MDR and IVDR requirements:

Scope and Classification of Products
Devices shall be divided into one of four device classifications, I, IIa, IIb, III. The device classification depends upon the intended purpose of the devices and their inherent risks. Classification criteria and rules shall apply to devices and accessories separately. MDR Annex VIII contains the device classification criteria and rules. Classification decisions with associated EU-MDR Annex VIII rule numbers and the rationale shall be documented in the applicable technical documentation file. Rules have been tightened and changed for some products, resulting in the reclassification of some products to a higher class.

Periodic Safety Update Report (PSUR)
A periodic safety update report should be completed for all Class IIa, IIb, and III medical devices according to Article 86 and all Class III devices must submit their periodic safety update report to EUDAMED. This requirement of class IIa devices is once every two years. PSUR includes the major findings of your post-market surveillance, all data from usage of your device and sales volume, and any results from your risk-benefit analysis.

Incidents and Field Safety Corrective Actions (FSCA)
Your standard operating procedure should be updated to reflect new requirements in templates or forms for reporting incidents and FSCAs with comprehensive timeline requirements.

Vigilance
Serious incidents (MIR) and field safety corrective actions (FSCA) are submitted through an electronic system (EUDAMED-article 92) to the relevant competent authorities. When the electronic system is not functional, the notified body shall be informed directly and simultaneously to the relevant competent authority for each vigilance report.

Unique Device Identification (UDI) and Labelling
Another significant change introduced in the new medical device regulation is the unique device identification (UDI) requirements. You can report field safety corrective actions and serious incidents using UDI. It provides identification and traceability of devices. It shall contain a UDI device identifier (UDI-DI) specific to the manufacturer and device and a UDI production identifier (UDI-PI) to identify the unit of device production. UDI is placed on the device label or packing with a declaration of conformity.

How do you minimize your business risk impact?
To minimize the impact of business risk, it is important to align your device’s technical documentation with your QMS. This can be made possible with a gap assessment between the two to identify the areas where alignment needs to improve. Get written commitments from the NB and understand the NB’s resource constraints upfront. Assign a point person for communication between the NB and the company — to minimize any confusion and delays. Plan for delays, implement risk mitigations, build in buffer time, communicate within the NB team and escalate to top management if needed.

Manufacturers keep good and transparent QMS records to simplify both EU MDR and IVDR compliance. ComplianceQuest’s EQMS software can easily collect, store, update, and share the record-keeping requirements from IVDR, MDR, FDA, etc.

Listen to this webinar titled “Real-World Lessons from Companies Navigating the Challenges in Achieving EU MDR Certification” to learn more.
http://www.compliancequest.com/webinar/achieving-eumdr-certification/

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