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EU MDR (2017/745) Medical Device Compliance

The EU Medical Device Regulation (MDR) is far more complex than the Medical Devices Directive (93/42/EEC) it replaces and presents new challenges for manufacturers. Classification has changed for some product categories and strict new requirements have been imposed on clinical data, risk management, postmarket surveillance, and supplier management.

Oriel STAT A MATRIX brings a proven process, procedures, and tools to support your transition efforts.

A comprehensive EU MDR readiness assessment identifies gaps in need of immediate attention

It’s critically important to understand your current level of compliance with the upcoming European Medical Device Regulation (EU MDR). An Oriel STAT A MATRIX EU MDR readiness audit – which can be specifically targeted or fully comprehensive – provides the clarity you need. The resulting output is a Transition Action Plan that documents necessary tasks, resources, and timelines to address identified gaps.

Once gaps have been identified we can assist you in closing them one by one, focusing on the areas that pose the greatest risk and impact on compliance (e.g., risk-based product classification or reclassification, clinical evidence and clinical evaluation, UDI, Technical Documentation, etc.). Another advantage of working with Oriel STAT A MATRIX is that we are a consulting company, so we are able to provide advice on how to fix the gaps we find.

See how we helped one mulitnational device company get its facilities ready for EU MDR.

 

Creating a strategy for how and when to transition your devices from the MDD to the EU MDR

Companies with limited internal resources and sizeable medical device portfolios often need help planning how and when to transition Medical Devices Directive (MDD) certifications to the MDR. Oriel STAT A MATRIX can work with you to plan out the entire portfolio transition through mid-2024, ensuring uninterrupted access to the European market while alleviating the impact on your financial and staffing resources.

If you have legacy products that have been on the European market for decades, we can also help you determine whether the data contained in your Clinical Evaluation Report will meet new MDR and MEDDEV 2.7/1 rev 4 requirements.

CER and Risk Management File Assessment

The release of MEDDEV 2.7/1 Rev 4 and the MDR within a few years of one another put a bright spotlight on clinical data and risk files. Many companies are still struggling to get their clinical evaluation reports and risk management files ready to withstand Notified Body scrutiny. Our team can review your CERs and risk files and assess whether you have established, documented, implemented, and are maintaining a system for risk management as part of the quality system.

Evaluating your Postmarket Procedures (PMS)

A major initiative for the EU MDR regulation was to strengthen PMS effectiveness. We can evaluate your PMS and ensure that proactive methods and responsibility are clearly defined and implemented. We support the development of procedures and their implementation, including providing your team with the proper training and coaching to sustain the PMS.

Our EU Medical Device Regulation training arms your team with the knowledge they need to succeed

Regardless of whether you make simple Class I instruments or Class III implants, the MDR is definitely not business as usual. The changes are significant, and it is important that everyone on your quality and regulatory teams have a full understanding of the changes and how they impact your compliance procedures.

  • To properly understand the changes and how they affect your product portfolio, consider our 3-day EU MDR transition training.
  • To learn how to conduct internal and supplier audits to the EU MDR, consider our EU MDR auditor training.
  • To learn all aspects of assembling a CER from the ground up as well as improving your existing clinical evaluation to meet new requirements, consider our EU CER training class.

These classes are conducted in numerous cities or can be brought to your facility.

Let us help you make a smooth transition to the EU MDR. Contact us today for a proposal or more information.

Classes are available as in-person or virtual instructor-led trainings. Select a course to learn more or to register.
 
Course Name Public Private
EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
Implementing the EU’s New Medical Device Regulation (MDR 2017/745)
New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance

Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.

Learn the latest in EU MDR interpretation gleaned from our work with Notified Bodies, EU thought leaders, and device organizations making the transition.  Click to learn more.

Learn all aspects of clinical evaluation from planning to postmarket clinical follow-up so your CERs can withstand Notified Body scrutiny. Click to learn more.

Get answers right now. Call 1.800.472.6477

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