The European Union Medical Device Regulations (MDR), Regulation (EU) 2017/745, and In Vitro Diagnostics Regulations (IVDR), Regulation (EU) 2017/746, were published in the Official Journal of the European Union on May 5th, 2017, which triggered a formal implementation and transition timeline. The EU MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Active Implantable Medical Devices Directive (90/385/EEC). The new rules will only apply after a transitional period of three years for medical devices and five years for in vitro diagnostic medical devices. The rules extend to new medical devices previously not governed by the directive and aim to increase the scrutiny of implantable devices. Additionally, the law targets tightening and improving the full device lifecycle in an effort to increase patient safety. 

The EU MDR brings significant new compliance requirements across the full medical device lifecycle. The following are key highlights:

• New guidelines for clinical evidence and safety requirements      
• Increased transparency and traceability, requiring the use of Unique
  Device Identification (UDI) across the device lifecycle and registration of Economic Operators 
• Increased designation requirements for Notified Bodies, as well as stronger mandates related to medical device assessment and safety standard consistency
• Premarket data requirements for high-risk devices, including definition and application of common specifications     
• Mandatory, continuous, and time-bound updates on device information, registration, clinical investigations, and vigilance to be supplied to the European databases for medical devices (Eudamed)
• Increased governance oversight to ensure consistency of standards enforcement (e.g., Medical Device Coordination Group, Expert Panel, Expert Laboratories)

EU MDR compliance requires a comprehensive, multi-disciplinary approach that spans functional areas within R&D, supply chain, quality management, and others. 

After careful evaluation and analysis of the new legislation, KPMG has developed a comprehensive framework to assist clients with assessing the compliance impact on their EU businesses.  In addition, KPMG created a four-phased implementation model consisting of 1) impact assessment and roadmap, 2) pilot implementation, 3) implementation and remediation, and 4) a sustaining and monitoring program. 

Impact Assessment and Roadmap

The impact assessment focuses on identifying how key requirements within the EU MDR legislation effect the overall portfolio, pinpointing key gaps and remediation needs, and developing a compliance roadmap. This assessment requires a cross-divisional team representing R&D, clinical, safety, quality management, regulatory, manufacturing & operations (including supply chain operations), and information technology.  

Pilot Implementation

Depending on the gaps discovered during the impact assessment, an organization may choose to conduct a short pilot project where chosen products are taken through the entire remediation lifecycle, including reviews with the Notified Bodies. 

Implementation and Remediation

The implementation phase, which includes comprehensive remediation activities, includes a multi-year schedule that accommodates the long lead time of some of the impacted clinical activities. The remediation program takes into consideration functional area dependencies, resource alignment, and critical risk management issues.

Sustaining and Monitoring Program

It is important to continuously monitor the progress of remediation efforts and leverage the learnings to further improve business processes. All products under development should also be monitored for EU MDR compliancesupporting the sustainability and frequency of the added EU MDR requirements for updates and compliance.

KPMG has the knowledge and experience, in addition to relevant accelerators that we have developed, to support your EU MDR compliance journey.  

Some (or all) of the services described herein may not be permissible for KPMG audit clients and their affiliates.