Comprehensive EU MDR Implementation Assessment
We’ll examine your quality management system (QMS) and Technical Documentation and then develop an actionable “roadmap” detailing tasks and resources required to make your organization compliant to the EU MDR. Output of the assessment will be determined by priority – each finding will be related to a task on a customized Implementation Quality Plan.
EU MDR Notified Body Preassessment Audit
Leveraging proprietary EU MDR assessment tools, we evaluate and document observations throughout the quality and regulatory system areas that are impacted by the new requirements. The audit provides you with a comprehensive understanding of your overall compliance to the EU MDR’s quality and regulatory requirements. Because we’re not a Notified Body, we can make specific recommendations for addressing findings.
Technical Documentation Assessment, Development, and Gap Closure
The new EU MDR takes a much broader approach to Technical Documentation requirements and includes more detailed requirements for quality management systems. Notified Bodies will spend more time linking information in Technical Documentation to support how device safety and performance are maintained – this includes linking to Clinical Evaluation Reports (CERs), risk management reports, design controls, manufacturing process controls, and postmarket surveillance. We can assess the gaps between your current processes and the new Technical Documentation Annex I requirements, review your Technical Documents, support the creation of missing documents, and/or coach your team to update and maintain Technical Documents.
CER Assessment, Development, and Gap Closure
The 2016 release of MEDDEV 2.7/1 rev 4 expanded the requirements for clinical data, and the EU MDR reinforces this requirement. We can assist with the development of new CERs as well as assess your current CERs. We can also support your team to make the necessary updates needed to meet the EU MDR’s expanded requirements related to postmarket surveillance, the process of clinical evaluation, and execution of necessary clinical evaluations, as well as risk management.
Risk Management File Assessment, Gap Closure, and Coaching
The EU MDR has a more universally risk-based approach compared to the MDD. It also aligns requirements for medical devices more closely with the harmonized standard for risk management (ISO 14971) and requires manufacturers to implement a risk management system in the QMS. We can assess whether you have established, documented, implemented, and are maintaining a system for risk management as part of the quality system. We can review your risk management file, help develop the file, and coach your team to support this critical area.
Unique Device Identification (UDI) Implementation Strategy
UDI has been specifically included as a requirement in the EU MDR to ensure proper traceability of products throughout the distribution chain and by the user. While the system has yet to be launched, it is understood that it will be similar to current systems in place in the United States. We can help you plan for UDI implementation and assist you with designing the UDI system to ensure that changes to medical devices and their labeling and packaging are properly controlled. On 17 May 17, 2021, the European Commission launched a new helpdesk to support economic operators in implementing the obligations and requirements introduced by the new UDI system. You can access the helpdesk know more.
Postmarket Surveillance (PMS) Assessment, Development, Gap Closure, and Coaching
A major initiative for the EU MDR regulation was to strengthen the PMS of medical devices placed on the market. Manufacturers now need to comply with new requirements for planning, reporting, and trending of product-related information. This includes introducing reports called Periodic Safety Update Reports (PSURs) that will be uploaded to EUDAMED. 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
EU MDR Regulatory Strategy Development
We determine classification of the device, identify testing requirements, and specify all inputs needed for Technical Documentation. The deliverable is a specific regulatory strategy that details the most efficient and cost-effective manner in which to proceed, enabling your product to be CE Marked.
Foundation through advanced training on EU MDR
We offer the following training classes on EU MDR related topics:
These classes are conducted as open enrollment in person and virtual instructor-led trainings. They can also be delivered exclusively for your organization.
Let us help you comply to the EU MDR. Contact us today for a proposal or more information.