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EU MDR (2017/745) Medical Device Compliance Consulting

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. 

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

Although the EU MDR does not take effect until May 2020, products with valid CE Marking certificates can continue to be marketed until May 2024. 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.

An EU MDR readiness assessment/mock audit identifies areas in need of immediate attention

It’s critically important to understand your current level of compliance with the upcoming European Medical Device Regulation. An Oriel STAT A MATRIX EU MDR readiness audit provides the clarity you need. This audit can be very targeted or comprehensive, and 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 they have 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

Closing the gaps so you are ready for your next Notified Body audit

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 re-classification, clinical evidence and clinical evaluation, UDI, technical documentation). 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.

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 fully understand the changes and how they affect your product portfolio, consider our 3-day EU MDR training class conducted in numerous cities or at 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!   EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)

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.

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

7 Ways The New EU Medical Device Regulation Will Change Your Approach to CE Compliance

Case Study: Clearing the Path to EU MDR Compliance

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