EU MDR Consulting & Regulatory Writing Services
GLOBAL provides comprehensive EU MDR and CER regulatory consulting and submission services
End-to-End Support for EU MDR Compliance & Submissions
The EU Medical Device Regulation (MDR) significantly raises the bar for clinical evidence, post-market oversight, and documentation structure. Our EU MDR regulatory strategy services ensure you meet these expectations with clarity, consistency, and efficiency.
EU MDR Regulatory Strategy Tailored to Your Needs
At GLOBAL, we deliver EU MDR consulting, regulatory writing, and submission support tailored to help medical device companies achieve and maintain EU MDR compliance. Whether you're launching a new device, updating legacy documentation, or navigating feedback from a Notified Body, our experts provide strategic guidance and high-quality documents across all MDR deliverables.
We can help you:
- Conduct gap analyses for your EU MDR documentation
- Compile CERs that integrate clinical, PMS, and PMCF data into a compelling and audit-ready compliance story
- Respond to Notified Body questions and prepare supporting documentation related to your CER and technical file
- Plan and manage CER projects by prioritizing device portfolios based on class, legacy status, and risk
700 + CERs Filed Successfully
35 + Satisfied Clients
23+ Writers and Consultants
Our EU MDR Documentation Services Include:
Define your methodology and review strategy:
- Defining the clinical evaluation scope, including accessories and devices used in combination
- Alignment with CER scope and claims
- Developing literature search protocols
- Establishing methodologies for other clinical data sources
- Justifying the clinical evaluation strategy
Our CER authoring services deliver fully MDR-compliant reports, including:
- Defining safety and performance outcomes with acceptance thresholds
- Incorporation and analysis of PMS, PMCF, and other clinical data
- Conducting MDR-compliant systematic literature reviews
- Building strong equivalence arguments with clinical, technical, and biological data
- Evaluating clinical evidence to support GSPR alignment
- Performing device-specific risk-benefit assessments
Proactively manage safety with strategic planning:
- Designing PMCF activities aligned with clinical evaluation objectives
- Defining endpoints and data collection methods for post-market follow-up
- Developing MDR-compliant PMCF Plans and Reports
- Analyzing and presenting PMCF data to support ongoing safety and performance evaluation
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Clear, layperson-friendly summaries designed for publication:
- Class III and implantable device SSCPs
- Reviewed for clarity, scientific accuracy, and audience relevance
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PMS plans, Reports, and PSUR development to meet Article 86 obligations with:
- Cumulative benefit-risk evaluations
- PMS Plans and Reports structured per MDR Annex III
- Integrated safety signal analysis
- Class IIa, IIb, and III submissions
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Determine the appropriate regulatory and clinical activities to achieve EU MDR compliance:
- Providing guidance on new product development and regulatory strategy
- Conducting clinical and regulatory gap assessments
- Developing standard operating procedures and supporting templates
- Establishing pre- and post-market clinical evidence strategies
- Supporting Notified Body response strategy and execution
- Planning technical documentation remediation efforts
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Organize your portfolio by:
- Creating, optimizing, and maintaining schedules for EU MDR deliverables
- Building and implementing standard project timelines, establishing processes, and mapping dependencies across workstreams
- Determining resource projections for short-, medium-, and long-term planning
- Implementing tracking and projection tools to improve team efficiency
Read more at our blog!
Expert MDR Consulting for Medical Devices
We support Class I, IIa, IIb, and III devices across all therapeutic areas
We provide regulatory writing support for manufacturers that want to meet notified body expectations in the first round of review. Whether you need help writing a single CER or help managing technical files for your entire portfolio, GLOBAL is here for you.
Why Choose GLOBAL for EU MDR Submission Support?
By partnering with GLOBAL, you can choose how best to utilize our experience.
- Boutique writing shop that will tailor our services to your needs
- Proven track record with zero major CER nonconformities
- Experts in EU MDR CER literature review process
- Seamless integration of strategy, writing, and project management
- Flexible engagement models: consulting, augmentation, or full outsourcing
- Deep knowledge of clinical, regulatory, and scientific standards
Frequently Asked Questions About EU MDR
What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a regulatory document required under EU MDR that summarizes the clinical data, literature, and post-market experience supporting the safety and performance of a medical device. It’s a cornerstone of the EU technical documentation and must be updated regularly.
Who is required to submit a CER under EU MDR?
All medical devices—regardless of class—must have a CER to demonstrate EU MDR compliance. For Class IIa, IIb, and III devices, CERs are subject to increased scrutiny by Notified Bodies and must follow the methodology outlined in MDR Annex XIV, Part A and MEDDEV 2.7/1 Rev 4.
How often do CERs need to be updated?
CERs should be updated:
- Annually for Class III and implantable devices
- As needed for lower-risk devices, based on post-market surveillance (PMS) data and clinical risk
- Updates are also required when there are significant changes to the device, indications, or safety profile.
What is the difference between a CER and a CEP?
The Clinical Evaluation Plan (CEP) outlines the methodology and scope of the evaluation before it is conducted. It defines the literature review process, data sources, and endpoints. The CER is the outcome—it presents and interprets the data to support the device’s safety and performance.
What are some of the literature review requirements for a CER?
This process supports the evaluation of clinical evidence and is critical to Notified Body acceptance. A systematic literature review must be reproducible and transparent, based on defined inclusion/exclusion criteria, and aligned with the device's intended purpose and risk profile.
What if I don't have clinical data—can I still write a CER?
Yes - a clinical evaluation is still required. In the event that you don’t have clinical data for your device, you need to consider your strategy. Does Article 61(10) apply? Can you claim equivalence? Can you justify a lack of clinical data based on risk class and ongoing PMCF? Reach out to our team to discuss options and we can work with your specific needs.
Which documents need to be aligned with the CER?
Alignment is key to EU MDR documentation services. The CER must reference and be consistent with PMS Plan and Reports, PMCF Plan and data, and risk management documentation. We offer end-to-end CER writing services that ensure this consistency across your technical file.
What are PMS Plans, PMS Reports, and PSURs?
PMS Plans outline how post-market data will be collected and analyzed. PMS Reports (Class I devices) summarize findings and corrective actions. Periodic Safety Update Reports (PSURs) (Class I, IIa, IIb, III) provide a detailed analysis of post-market performance and safety trends. We create MDR-compliant PMS documentation that meets the structure outlined in Annex III.
What is a PMCF Plan and Report?
Post-Market Clinical Follow-up (PMCF) is a proactive process under MDR. PMCF Plans define clinical follow-up activities, endpoints, and methodologies. PMCF Reports summarize the outcomes and feed into CER and risk documentation
Our team develops these deliverables to ensure full lifecycle compliance.
How can I prepare for a Notified Body review of my CER or technical documentation?
Preparation includes supporting all claims with traceable clinical evidence, ensuring alignment between CER, PMS, PMCF, and risk documents, and resolving gaps or inconsistencies proactively. We offer technical file reviews and response strategy support for Notified Body queries.
Do you support legacy devices?
Yes. EU MDR compliance for legacy devices is one of our specialties. We help manufacturers justify continued use of legacy devices by leveraging historical data, planning PMCF activities to address evidence gaps, preparing MDR-compliant justification. Understanding your specific device and using the most appropriate strategy for your legacy device under the MDR, identifying data gaps and advising on PMCF strategy, and articulating clear rationales for approach and clinical data included in your CER will support compliance.
How long does it take to prepare EU MDR deliverables?
CERs can be a lot of work! The time to complete a CER for a single writer can range from 4-12 weeks depending on the submission strategy, device history, and available clinical data. However, GLOBAL’s large, integrated team structure can support accelerated timelines of as little as 2 weeks for your CER emergencies. We offer flexible project planning and accelerated support based on your needs.
What other EU MDR services do you provide?
We offer end-to-end MDR support, including gap assessments and strategy development, technical documentation remediation, SOP development and training for internal teams, Notified Body response preparation, project planning, resourcing, and tracking tools.
Ready to start?
Let us guide you through best practices for CER development and comprehensive EU MDR documentation services. From end-to-end CER writing services to Notified Body response support, GLOBAL is your trusted partner.
