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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. 

Whether you need expert advice, limited assistance, or full implementation support, we offer a comprehensive array of flexible options to support your needs.

Just getting started with your transition to the new EU MDR?

Comprehensive EU MDR Transition Assessment

We’ll examine your quality management system (QMS) and Technical Documentation and develop an actionable “roadmap” detailing tasks and resources required to transition your organization to the new regulation. Output of the assessment will be determined by priority – each finding will be related to a task on a customized Transition Quality Plan.

Already closed the gaps and need to kick the tires before your Notified Body audit?

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.

Unsure about the suitability of your Technical Documentation?

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, 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 generation of missing documents, and/or coach your team to update and maintain Technical Documents.

Unsure if your Clinical Evaluation Reports will withstand Notified Body scrutiny?

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 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.

Want to ensure your risk assessments meet MEDDEV 2.7/1 rev 4 and ISO 14971:2012?

Risk Management File Assessment, Gap Closure, and Coaching

The new EU MDR adopts 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 (EN ISO 14971:2012) 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. 

Want to better understand EU Unique Device Identification (UDI) requirements?

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.

Looking to have outside experts review your postmarket surveillance (PMS) procedures?

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 will need to comply with new requirements for planning, reporting, and trending of product-related information. This includes introducing new 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

Bringing a new medical device to market in the EU?

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.

Need to train your team

Foundation through advanced training on EU MDR 

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 EU MDR implementation training.
  • To learn how to conduct internal and supplier audits to the EU MDR, consider our Exemplar Global-certified 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 as open enrollment in person and virtual instructor-led trainings.  They can also be delivered exclusively for your organization.

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)
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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