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Transition to the new EU Medical Device Regulation (MDR)

The new EU regulations are much tougher than the directives they are replacing, and they will transform the way you do business in the EU.

In May 2017, the European Union (EU) published new regulations for device manufacturers (MDR) and in vitro diagnostic manufacturers (IVDR). These new regulations will replace the three existing EU directives covering medical devices and IVDs. Medical device manufacturers will have a 3-year transition period, and IVD manufacturers will have a 5-year transition period.

Oriel STAT A MATRIX can help you prepare for the new regulations so you can continue to sell your medical devices in the EU.

Training
Understand the EU MDR


In our new 2-day course Transition to the New EU Medical Device Regulation (MDR), you will learn about the key changes introduced in the MDR, and how develop an effective transition plan.  This course is offered in 12 cities across the US, or we can deliver it at a location of your choice. Upcoming sessions.

Baseline Audits

Assess your Product Portfolio - 
Evaluate how the changes to classification criteria will affect your products. 

The regulations include new, risk-based classification systems that change the classification of some medical devices under the MDR and a significant number of IVDs under the IVDR.  A product portfolio audit identifies the products affected by the new classifications, and identifies the additional clinical evaluation and technical documentation required.

Conduct a Comprehensive Regulatory Audit

The comprehensive audit examines the organization’s current state against the requirements in the EU regulations along with the full range of global changes impacting device manufacturers, such as ISO 13485:2016 and MDSAP. Our auditors use a process-based audit methodology to perform the assessment and identify the gaps. During the assessment, they also provide insight into the expectations of the third-party auditors.

Both assessments conclude with a list of action items, as well as a Transition Action Plan that documents the resources and timelines needed to close the identified gaps.

Close the Gaps
Take action

Implement the Transition Action Plan, concentrating on the areas that pose the greatest risk and impact on compliance (i.e., risk-based product classification or re-classification, clinical evidence and clinical evaluation, UDI, technical documentation).

Oriel STAT A MATRIX is a training and consulting company, so our consultants can provide advice for fixing any gaps or nonconformities uncovered during your assessment audit – via coaching, guidance, or actual work actions.

Prepare for the 3rd Party Audit
Final dress rehearsal

You’ve prepared, and now it’s time for a final run-through before the real event. In this preassessment audit, our auditors mimic the official third-party audit, using the same process approach and risk-based thinking as the Notified Bodies to review your implementation of the MDR/IVDR requirements.  The audit will help you identify any issues before your Notified Body audit, allowing you time to plan and implement corrective actions. 

 

The Medical Device Regulation (MDR) 2017/745/EU and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746/EU were published in May 2017, after five years of development. They are the first major changes to the EU medical device regulatory environment in more than 20 years and will replace the three existing medical device directives.

Why were the new regulations developed?

The new regulations were developed to improve device safety in response to major medical device scandals (e.g., those involving hip and breast implants), and to address industry changes that had arisen since the Medical Device Directives were released in the 1990s. In addition, the replacement of the three directives with two regulations establishes a stronger and more consistent framework of requirements for medical devices in the EU.

When will the EU medical device and IVD regulations apply?

The new regulations were published on May 5, 2017. They “entered into force” 20 days later, on May 25, 2017, which started the transition clock.

  • The MDR has a 3-year transition period; it applies starting on May 26, 2020.
  • The IVDR has a 5-year transition period; it applies starting on May 26, 2022.

When does my current CE Mark expire and require me to transition to a CE Mark under the MDR or IVDR? 

Certificates issued by Notified Bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to May 25, 2017 will remain valid until the end of the period indicated on the certificate. Certificates issued after the regulations come into force will remain valid until the end of the period indicated on the certificate, which shall not exceed five years from when the regulations come into effect, May 27, 2024. The industry expects that Notified Bodies will strongly encourage manufacturers to “upgrade” their CE Marks throughout 2018 and 2019.

Existing IVD certificates have the same last date of validity: May 27, 2024.

Important: “General IVDs” are those that were not required to have CE certificates under the IVDD that could be “self-declared.” The IVDR requires those reclassified General IVDs, which make up the bulk of the IVD market, to have a Notified Body intervention and obtain a certificate before the application date of May 26, 2022.

Summary of relevant dates

  • Publication date: May 5, 2017
  • Entry-into-force date: May 25, 2017
  • Date of application:
    • MDR: May 26, 2020
    • IVDR: May 26, 2022
  • MDD/IVDD CE certificates not valid after May 27, 2024

What are some of the key changes in the new EU device regulations?

New product groups and classification rules. 

The regulations include changes to device and IVD classification rules. In the MDR, these changes mostly impact devices that are reusable surgical instruments, software-only products, higher-risk devices, and combination products. In the IVDR, however, there is a new risk classification system that impacts all IVDs, especially those IVDs that are eligible for self-certification under the current directive. Manufacturers will need to perform portfolio reviews and determine which, if any, of their products will be reclassified under the new regulations. 

More rigorous clinical evidence requirements. 

Under the regulations, manufacturers must know how to assess the benefit-risk for the finished medical device from a clinical perspective and manage design changes, perform risk management, and conduct clinical evaluation activities.  

Stricter control on what manufacturers can “claim” for their device.

The clinical evaluation of a device must support the intended use of the device, and show the relationship of risk management and the clinical evidence – how the device is actually used throughout its life cycle. Manufacturers must continually assess the safety and effectiveness of the device while it is on the market and provide required follow-up information as specified in the regulations.

More stringent postmarket surveillance (PMS) requirements. 

The MDR and IVDR require more postmarket surveillance data collection and reporting for all classes of devices, not just high-risk devices. The regulations expect all device manufacturers to perform postmarket surveillance proactively, understand how their device is used throughout its life cycle, and know how to feed postmarket data back into the quality system. Manufacturers of specified device classes will prepare a Periodic Safety Update Report (PSUR) for each device and, where relevant, for each category or group of devices. The PSUR summarizes the manufacturer’s analysis of postmarket surveillance data. The regulations include specific requirements related to the inclusion of PSURs in the technical documentation, their submission, and how often they are to be updated.

Stricter control over suppliers. 

The regulations increase controls around traceability and transparency within the whole supply chain.

Expanded concept of technical documentation and increased requirements for technical information.

The regulations change the intent of technical documentation, introduce new terminology, and expect greater availability of all technical information. These changes will have a significant impact on how companies manage their records. Manufacturers must understand the entire life cycle of their device, including the impact of changes on products already on the market.

Other changes:

  • Enhanced labeling and packaging requirements
  • New Unique Device Identification (UDI) requirements
  • Requirement of a designated “Responsible Person” for regulatory compliance


How will the new regulations affect Notified Bodies (NB)?

One aim of the regulations is help to strengthen the position of Notified Bodies in their relationships with manufacturers. While there is a much stronger emphasis on regulatory compliance, the intent of the regulations is that Notified Bodies and manufacturers partner together in ensuring that safe and effective devices are placed on the market.

The regulations, in turn, impose new responsibilities on Notified Bodies, including requirements related to their staff qualifications and notifying an expert committee when they receive applications for high-risk and novel devices.

What is Eudamed/EUDAMED?

Eudamed (sometimes rendered as EUDAMED) refers to the European Databank on Medical Devices.  The European Commission is required to establish this databank by 2020. Eudamed will serve as a central, web-based portal for information about medical devices in the EU. The MDR and IVDR require manufacturers to submit specific information to Eudamed. This information will be available to the European Commission and the Competent Authorities. Some information will also be available to the public, including summaries of safety and performance information for Class II and implantable medical devices.

The goal of Eudamed is to improve the transparency of and access to information about medical devices in the EU.

Will the new EU regulations be included in MDSAP?

At this time the EU is not participating in the Medical Device Single Audit Program (MDSAP).  Currently five countries – the US, Australia, Brazil, Canada, and Japan – are taking part, with Health Canada making a full transition to the program starting in January 2019. 

Will the new MDR and IVDR require EN ISO 13485:2016 certification?

Fundamentally yes. Although the regulations do not require certification to a specific EN ISO standard, medical device companies must establish and implement a quality system that meets a number of compliance requirements outlined in the new Medical Device Regulation and In Vitro Diagnostic (IVD) Regulation.
 

Select a course below to learn more or to register.
 
Course Name Public On-site
New!   Transition to the New EU Medical Device Regulation (MDR)

In this new 2-day course you will learn about the new requirements in the MDR and how to plan an efficient transition. Click to learn more.

Provided below are a variety of practice related white papers, market updates and case studies.

The New EU Medical Device Regulations: What You Need to Know

Pathfinder for the New EU MDR and IVDR

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