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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.

Will your technical documentation pass muster during your next Notified Body audit? How will you handle the transition? We can help. 

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.

Our audit includes an assessment of:

  • Current device(s) classification and whether it has changed under the EU MDR
  • Robustness of clinical evaluation and technical documentation
  • Risk management files and procedures
  • Clinical Evaluation Reports (CER) and literature reviews
  • Postmarket surveillance processes
  • Economic Operator agreements, including your EC Rep agreement
  • Procedures for managing your supply and distribution chains
  • Relations with your current Notified Body
  • Product life-cycle plans

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.

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.

Both 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.

Select a course below to learn more or to register.
Course Name Public On-site
New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance
EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)
New!   EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)

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.

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

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

Learn key changes between IVDD and IVDR, discusses how to make the transition, learn best practices for transitioning. Click to learn more.

Get answers right now. Call 1.800.472.6477