EU MDR & IVDR Regulatory Consulting

EU Post-Market Surveillance (PMS)

Under the European Medical Device Regulation (MDR) EU 2017/745 and the In Vitro Diagnostic Regulation (IVDR) EU 2017/746, manufacturers are required to implement and maintain a robust Post-Market Surveillance (PMS) system for all medical devices and in vitro diagnostic devices, regardless of their classification. PMS activities are essential for continuously monitoring the safety and performance of devices once they are available on the market.

NAMSA’s dedicated team of experts, comprising seasoned medical writers and regulatory specialists, including former Notified Body staff, provides comprehensive support in developing and executing effective PMS activities. Our services include:

• PMS Plan Development
• Data Analysis
• Regulatory Compliance
• PMS Report

By partnering with NAMSA, manufacturers can ensure their PMS activities not only meet regulatory standards but also enhance the overall safety and efficacy of their medical devices.

IVD Performance Evaluation Plans and Reports

Our IVD Performance Evaluation Plans (PER) and Reports (PER) service offers comprehensive support to In Vitro Diagnostic (IVD) manufacturers, ensuring compliance with the EU In Vitro Diagnostic Regulation (IVDR) and Notified Body requirements.

Our expert medical writing and regulatory team conducts thorough evaluations of all IVD device classes and therapeutic areas, including combination products. PEPs are developed to ensure the data identification process is thorough and systematic, and the performance evaluation is continuously updated. Robust PERs are developed assessing the scientific validity, analytical performance and clinical performance data.

We will also conduct a detailed data analysis, risk assessment, and make strategic recommendations. In addition, our team of former Notified Body executives support the strategy and development of your performance evaluation documentation, providing an extra measure of assurance that your PER will satisfy your auditor.

Clinical Evaluation Plan and Report Writing

Whether your medical device has been on the EU market for decades, or you are pursuing a new CE Marking certification, NAMSA’s regulatory and medical writing teams are ready to help you gather, assess, and evaluate all necessary clinical evidence to support your submission or maintain postmarket compliance.

As one of the largest medical device clinical research organizations, we know what Notified Bodies expect to see in clinical evidence submitted by manufacturers. NAMSA has helped thousands of device manufacturers gather the data to support regulatory submissions and maintain postmarket compliance.

Summary of Safety and Clinical Performance (SSCP)

The European Medical Device Regulation (MDR) EU 2017/745 requires that manufacturers of implantable and class III devices (other than custom-made or investigational devices) must create a Summary of Safety and Clinical Performance (SSCP). The SSCP document is intended to provide public access to an updated summary of clinical data and other information about a medical device’s safety and clinical performance for healthcare professionals and, if relevant, patients.
This obligation is in addition to the requirement for creating a Periodic Safety Update Report (PSUR).

NAMSA’s experts have carefully analyzed the MDR requirements and recommendations and associated guidance documents to help clients navigate through this early period of enforcement with ease and confidence. Our EU regulatory and medical writing teams have the expertise and knowledge to create SSCPs tailored towards intended users/healthcare professionals and patient/lay audiences in compliance with these regulatory requirements.

EU MDR Technical Documentation

The European Medical Device Regulation (MDR) requires manufacturers to prepare detailed Technical Documentation to obtain and maintain CE-Marking of medical devices. In most cases, this documentation will be reviewed by your European Notified Body and contains a wide array of information about your device: specifications, manufacturing process, design controls, test reports, risk assessments, clinical data, and much more.

Our team prepares MDR-compliant technical documentation for a wide range of devices and device families. Depending on your needs, we can provide a simple compilation of the technical documentation through to the writing of all key documents.

PMCF Plans, Surveys, and Reports

If you market devices in Europe, you already know that your clinical evaluation obligations under the EU Medical Device Regulation don’t end when you get CE Marking. The MDR requires you to proactively gather data to assess ongoing device safety and performance. Known as Post Market Clinical Followup, PMCF is an important part of your overall Post Market Surveillance (PMS) activities. NAMSA can help you strategize on which data to collect, how to collect it, and prepare a robust PMCF report that meets the expectations of your Notified Body.

IVD PMPF Plans, Surveys, and Reports

NAMSA helps In Vitro Diagnostic (IVD) manufacturers prepare Post-Market Performance Follow-up (PMPF) plans, surveys, and reports. We develop comprehensive plans tailored to your specific IVD product, facilitating systematic performance and relevant scientific data collection and analysis from the use of the device within its intended purpose. Our expert team supports you through:

• Strategy development
• Creation of tailored PMPF plans
• Gathering data via literature reviews, surveys, clinical performance studies, and more
• Writing comprehensive PMPF reports

We compile this data into insightful reports to confirm the safety, performance and scientific validity of your device as well as ensuring the acceptability of the benefit-risk ratio and detecting emerging risks. By leveraging our extensive regulatory expertise, we help you navigate IVDR and other global standards, ensuring your devices continue to be safe and effective throughout their lifecycle.

Periodic Safety Update Reports (PSUR)

The European Medical Device Regulation (MDR) EU 2017/745 requires the preparation of Post-Market Surveillance Reports (PMSR) or Periodic Safety Update Reports (PSUR), depending on device classification. A PMSR is intended for low-risk class I devices, while a PSUR is intended for moderate and high-risk devices (class IIa, IIb, III, implantable). Irrespective of whether a medical device has a valid certificate under the Medical Device Directive (MDD) 93/42/EEC or MDR, all manufacturers must comply with Post-Market Surveillance requirements outlined in the MDR.

NAMSA’s highly experienced medical writing team, together with our EU Regulatory experts, supports manufacturers in the development and submission of your PSUR. We offer tailored support to you, the medical device manufacturers, ensuring that every report meets the highest standards of accuracy and regulatory compliance. Our expertise spans across various device classes, providing you with the confidence that your PSURs are in capable hands. Partner with NAMSA to streamline your regulatory processes and maintain the highest levels of safety and performance for your medical devices.