End-to-End Support for EU MDR Compliance & Submissions
EU MDR Consulting & Regulatory Writing Services
The EU Medical Device Regulation (MDR) significantly raises the bar for clinical evidence, post-market oversight, and documentation structure. Our EU MDR regulatory strategy and writing services ensure you meet these expectations with clarity, consistency, and efficiency.
EU MDR Regulatory Strategy Tailored to Your Needs
At GLOBAL, we deliver customized EU MDR support 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 document authoring for 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 story
Respond to Notified Body questions and prepare supporting documentation related to your CER and technical file
Plan and manage CER updates by prioritizing device portfolios based on class, legacy status, and risk
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Our Services Include
Define your methodology and clinical evaluation strategy by:
- Determining the clinical evaluation scope, including accessories and devices used in combination
- Developing literature search protocols
- Establishing methodologies for collecting clinical data
- Justifying the clinical evaluation strategy
Our CER authoring services deliver fully MDR-compliant reports, including:
- Defining safety and performance outcomes with acceptance thresholds
- Managing the 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 conformance
- Performing device-specific risk-benefit assessments
Post-market Clinical Follow-up services, including:
- Defining endpoints and data collection methods for post-market follow-up
- Developing MDR-compliant PMCF Plans and Reports
- Analyzing and present PMCF data to support ongoing safety and performance evaluation
- Designing PMCF activities aligned with clinical evaluation objectives
Clear, summaries designed for EUDAMED publication:
- Drafting Class III and implantable device SSCPs
- Reviewing for clarity, scientific accuracy, and relevance to intended audiences
- Establishing appropriate reading levels for clinicians and patients
Using MDR Annex III, we will develop your PMS Plans and Reports and PSURS to meet Article 86 obligations. Our services include:
- Cumulative benefit-risk evaluations
- Safety signal analysis
- Class I PMS Reports
- Class IIa, IIb, and III submissions
- Periodic Safety Update Reports (PSURs)
- Adaption of EU MDR PSURS for regional submissions - UK PSURs per MHRA, ASRs per Health Canada, etc.
Our expert team can help you 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 templates
- Establishing pre- and post-market clinical evidence strategies
- Supporting Notified Body response strategy and execution
- Planning technical documentation remediation efforts
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
Our team offers full-scale training programs on every aspect of EU MDR and the clinical evaluation (CEP, CER, PMCF, PSURs, SSCP, etc.) including:
- Conducting short bootcamp trainings for your team
- Providing medium-term support to inexperienced teams
- Supplying guidance and mentorship on real projects
Read about GLOBAL's success stories with EU MDR, watch webinars & more on our blog!
Why Choose GLOBAL for eu mdr Support?
Expert MDR Consulting for Medical Devices
- Supports Class I, IIa, IIb, and III devices across all therapeutic areas
- Provides regulatory writing support for manufacturers that want to meet notified body expectations in the first round of review.
- 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, staff augmentation, or full outsourcing
- Deep knowledge of clinical, regulatory, and scientific standards
Frequently Asked Questions About INDs
A Clinical Evaluation Report (CER) is a living document created for initial EU market approval and updated periodically for the entire lifecycle of the device. The CER summarizes the device's clinical and non-clinical data and analyzes it against established safety and performance acceptance criteria to justify a favorable risk-benefit ratio. The CER is a cornerstone of the EU MDR documentation.
All medical devices—regardless of class—must have a CER to demonstrate EU MDR compliance. CERs must follow the methodology outlined in MDR Annex XIV, Part A and MEDDEV 2.7/1 Rev 4.
CERs should be updated periodically for a reassessment of the risk-benefit ratio as new clinical data emerges from post-market surveillance and PMCF:
- Annually for Class III and implantable devices
- Every 2-5 years 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.
The Clinical Evaluation Plan (CEP) outlines the methodology and scope of the evaluation before it is conducted. It defines the scope, data sources and collection methods, and relevant endpoints. The CER is the outcome—it presents and interprets the data to measure the device’s safety and performance, and establish a positive risk-benefit ratio, and demonstrate conformity with the relevant GSPRs.
Literature reviews for the clinical evaluation process must be systematic and reproducible. The literature review protocol must define the scope, search terms, databases used, justify the timeframe, and establish unambiguous inclusion/exclusion criteria. The systematic methods must demonstrate all relevant published clinical data was reviewed regardless of favorable or unfavorable results.
Yes - a complete and robust CER can still be written even if there is a lack of clinical data. 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? What are your options for generating and collecting clinical data to support the clinical evaluation? Reach out to our team to discuss options and we can work with your specific needs.
Inconsistencies between EU MDR documents are common Notified Body findings and slow down the review and approval process. 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.
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 IIa, IIb, III) provide a detailed analysis of post-market performance and safety trends. We create MDR-compliant PMS documentation that follows the structure outlined in Annex III.
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, PSUR, and risk documentation.
Preparation includes ensuring all claims are supported 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.
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, and preparing MDR-compliant justification. Understanding your specific device and using the most appropriate strategy for your legacy device under 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.
CERs can be a lot of work! The time to complete a CER for a single writer can range from 6-12 weeks depending on the submission strategy, device history, and available clinical data. However, GLOBAL’s large, integrated team structure can support accelerated timelines for your CER emergencies. We offer flexible project planning and accelerated support based on your needs.
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.
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