Medical Devices
Ensure your medical device meets regulatory standards with our expert Clinical Evaluation Reports (CER) services. We provide comprehensive support from data collection to evidence appraisal, helping you achieve compliance efficiently.
Enhancing Compliance and Market Readiness of Medical Devices Through Expert CER, Post-Market Surveillance, and Data Collection Services
The medical device industry plays a critical role in modern healthcare, delivering innovative solutions that enhance patient outcomes, improve diagnostics, and streamline treatment processes. Spanning a wide range of products from simple instruments to complex, technology-driven devices, this industry is at the forefront of medical innovation, combining engineering, biotechnology, and regulatory compliance to meet global health needs.
Navigating regulatory requirements for medical devices can be complex, and CERs play a critical role in demonstrating safety and performance in compliance with international standards such as the EU Medical Device Regulation (MDR 2017/745) and other global frameworks. A well-prepared CER not only supports regulatory submissions but also ensures that medical devices consistently meet the highest standards of clinical safety and effectiveness.
Post-market surveillance (PMS) further strengthens this process by monitoring the performance and safety of medical devices once they are on the market, focusing not only on quality assurance but also on regulatory compliance and timely reporting to local authorities. This proactive vigilance ensures cooperation with national authorities, enhances patient safety, and drives continuous improvement in medical device performance, ultimately safeguarding public health while supporting market sustainability.
Key Features Include:
- Clinical investigation of the device under evaluation.
- Clinical investigation or other studies reported in the scientific literature for an equivalent device.
- Peer-reviewed scientific literature reporting on other clinical experiences of the device being evaluated or an equivalent device.
- Clinically relevant PMS data with specific emphasis on post-market clinical follow-up (PMCF).
Our Expertise in Medical Devices Includes
We provide end-to-end support for medical device companies, helping them navigate the entire product lifecycle, from research and development to market access and PMS. Our services are designed to ensure compliance, efficiency, and safety, keeping patient welfare at the center of every solution.
Clinical Evaluation Reports (CERs)
Comprehensive preparation and maintenance of CERs to demonstrate safety and performance in line with MDR and ISO 13485 requirements.
Regulatory Submissions
Support for global regulatory compliance, including FDA, CE marking, and other regional approvals.
Post-Market Surveillance (PMS)
Collection, analysis, and reporting of post-market data to ensure ongoing device safety and compliance.
Risk Management & Vigilance Reporting
Guidance on ISO 14971-based risk assessments, incident reporting, and corrective actions.
Technical Documentation & Dossiers
End-to-end support in preparing high-quality technical files and design dossiers.
Medical Writing & Scientific Support
Professional scientific writing, clinical study reports, and regulatory documentation for devices ranging from Class I to Class III.
Medical Device Segments We Serve
At Pubrica, we provide specialized support across a wide range of medical device segments, helping manufacturers navigate regulatory compliance, clinical evaluation, and post-market requirements with precision and efficiency. Our expertise spans multiple device categories, ensuring tailored solutions for every stage of your product lifecycle. Key Segments Include:
How to Prepare a Clinical Evaluation Report for Medical Devices
A clinical evaluation takes place in four steps:
Establishing or Updating the Clinical Evaluation Plan (CEP)
The manufacturer establishes or updates the CEP to define the scope and document the clinical evaluation approach.
Identify Relevant Clinical Data
Identifying clinical data relevant to the device under evaluation, its intended purpose, and any gaps in the clinical evidence. Potential sources of clinical data include clinical investigation of the device being evaluated, PMS data, particularly PMCF, clinical literature, and equivalence data.
Appraise & Generate Data
Appraises the relevance, quality, and scientific validity of the clinical data. New or additional clinical data are generated as needed to address any gaps in the clinical evidence.
Demonstrate Clinical Evidence Sufficiency
Requires the manufacturer to provide sufficient clinical evidence for each relevant general safety and performance requirement (GSPR) that requires clinical data.Classes of Clinical Evaluation Report for Medical Devices
CER for medical devices is typically categorized based on the risk class of the medical device under regulations such as the MDR 2017/745 or other regional frameworks. The classes reflect the potential risk a device poses to patients. Here’s a detailed breakdown:
| Class | Description | Examples | CER Focus |
|---|---|---|---|
| Class I Devices (Low Risk) |
Non-invasive devices or those with minimal risk to the user. | Bandages, stethoscopes, examination gloves. |
• Clinical evaluation is often based mainly on literature review and well-documented experience. • Clinical data requirements are generally less stringent than those for higher-risk classes. |
| Class IIa Devices (Medium-Low Risk) |
Moderately invasive or pose moderate risk. | Dental fillings, infusion pumps, ultrasound equipment. |
• Requires more detailed clinical data than Class I.
• May include post-market clinical follow-up (PMCF) or limited clinical investigations. |
| Class IIb Devices (Medium-High Risk) |
Invasive or significant impact on patient health if they fail. | Ventilators, anaesthesia equipment,and implantable devices like pacemakers (non-life-sustaining). |
• CER must rely on robust clinical evidence.
• Usually requires clinical investigations or well-controlled studies in addition to the literature. |
| Class III Devices (High Risk) |
Devices that are life-sustaining or life-supporting, or have a high risk of serious health consequences. | Heart valves, implantable defibrillators, some orthopaedic implants. |
• Requires extensive clinical data from trials and real-world evidence.
• CER is a critical component for regulatory approval and must demonstrate safety, performance, and clinical benefit comprehensively. |
What Is the Importance of Post-Market Surveillance for Medical Devices?
PMS is important to ensure the safety, efficacy, and performance of medical devices after they are released to the market and used by the public.
Ensure Safety and Performance
Identifies unforeseen risks and device failures that enable fast mitigation of life-threatening or long-term injuries with the aid of a PMS strategy.
Monitor Real-World Use
Collects real-world performance data to uncover risks and limitations not evident in clinical trials.
Align with Regulatory Requirements
Aligns with EU MDR and US FDA requirements to ensure device safety, quality, and performance across its lifecycle.
What Post-Market Surveillance Guidelines Should the Medical Device Industry Consider?
PMS guidelines for the medical industry include references such as the Medical Device Guidance Documents (MEDDEV) and the Medical Device Coordination Group (MDCG) guidelines in the EU.
PMS guidelines from different organizations are listed below.
MEDDEV Guidelines
Guidance on how to conduct PMS and clinical evaluations in the EU.
MDCG Guidelines
Guidance on compliance with EU regulations, including detailed PMS and vigilance.
Health Canada
PMS ensures safety monitoring and license compliance for medical devices in Canada.
NMPA (National Medical Products Administration)
Requires PMS as part of the regulatory process for medical devices marketed in China.
DSMB (Data Safety Monitoring Boards) Guidelines
Often oversee clinical trials, including post-market phases.
IMDRF (International Medical Device Regulators Forum)
Provides global harmonized PMS guidelines to enhance medical device safety.
MHRA (Medicines and Healthcare products Regulatory Agency)
Mandates PMS for ongoing compliance and safety of medical devices in the UK.
COFEPRIS (Federal Commission for Protection against Sanitary Risks)
Requires PMS to maintain the safety and efficacy of medical devices in Mexico.
PMDA (The Pharmaceuticals and Medical Devices Agency)
Enforces strict PMS for the continued safety and performance of medical devices in Japan.
ANVISA (Brazilian Health Regulatory Agency)
Ensures medical devices in Brazil undergo comprehensive PMS monitoring.
TGA (Therapeutic Goods Administration)
Mandates PMS to uphold Australian safety and performance standards for medical devices.
Where Our Authors Publish
Our authors share Pubrica’s expert content in top-tier journals, conferences, and platforms, maximizing and amplifying its recognition and reach. Our placement will enhance our visibility and elevate our standing in an authoritative capacity.
Paper Title: Novel Approaches to Combat Medical Device-Associated Biofilms
Author: Xin Li, Luyao Sun, Peng Zhang, and Yang Wang
Journal Name: Coatings
Publisher: MDPI
Impact factor: 2.8
Our Expert Medical Editors
Pubrica’s team of industry specialists offers unrivalled expertise and perspectives to provide complete solutions with precision and originality. Through a mix of both experience and specialization, they strive for excellence in everything they do.
What Our Client Says About Us
Pubrica’s expertise in Clinical Evaluation Reports helped us meet stringent EU MDR requirements without delays. Their team provided in-depth literature reviews, well-structured analysis, and clear documentation that impressed both our internal auditors and regulators.
The CER prepared by Pubrica was comprehensive, evidence-based, and aligned with the latest regulatory expectations. Their subject matter experts ensured our Class II device submission sailed through smoothly.
We were struggling with MDR compliance for our clinical evaluation. Pubrica’s team stepped in with outstanding guidance, timely delivery, and high-quality CER documentation. Their support gave us confidence in facing notified bodies.
Testimonials
Learn how Pubrica’s meta-analysis service has empowered researchers to generate high-impact, publication-ready analyses that advance evidence-based research and elevate their academic and clinical visibility. Here is what our clients say:
"Pubrica’s team provided exceptional support throughout my meta-analysis cardiovascular drug efficacy. Their adherence to PRISMA guidelines and attention to statistical detail helped me publish in the European Heart Journal. Highly recommended"
— Dr. Anna Müller
Cardiologist, University Hospital Munich, Germany
"The meta-analysis manuscript I co-authored with Pubrica’s experts was accepted by BMC Public Health without major revisions. Their data synthesis and transparent methodology were critical to this success."
— Dr. Rohan Mehta
Public Health Researcher,
All India Institute of Medical Sciences (AIIMS), India
"Thanks to Pubrica’s guidance, our meta-analysis on paediatric nutrition was published in The Lancet Child & Adolescent Health. The methodological rigor and rewriting support were key contributors to the paper’s clarity and impact."
— Dr. Luis Fernández
Pediatrician & Research Fellow, University of Barcelona, Spain
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