EU Medical Device Regulatory Consulting Services

EU Regulatory Strategy and CE Marking Pathway

A clear and well-defined regulatory strategy is critical to navigating the complexities of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Without a sound strategy in place, manufacturers risk delays, noncompliance, or even denial of market access. A proactive regulatory roadmap ensures your development aligns with European regulatory expectations from the outset—streamlining CE marking, optimizing resource allocation, and reducing costly rework during the conformity assessment process.

For more than 40 years, we have been partnering with medical device and IVD developers to craft tailored strategies that consider device classification, intended use, risk level, and target markets. We guide you through the appropriate conformity assessment route—whether via a Notified Body or national derogation—and help you align your clinical, technical, and quality documentation with evolving EU requirements and harmonized standards. Our goal is to position your product for approval success and long-term regulatory compliance.

Our medical device regulatory strategy services include:

• Classification and regulatory pathway determination
• CE marking readiness assessments
• Gap analyses for legacy products
• Strategic planning for clinical and performance evidence generation
• Integration of Common Specifications and harmonized standards (e.g., ISO 14971, ISO 13485, ISO 10993)

Regulatory Meetings with Competent Authorities and Notified Bodies

When seeking to market your medical device or diagnostic in Europe, engaging proactively with National Competent Authorities and Notified Bodies can accelerate timelines and clarify regulatory expectations. ProPharma's team of regulatory experts supports manufacturers in preparing for formal and informal regulatory interactions across the EU. For medical devices, this may include clinical investigation applications, classification justifications, or requests for derogation. For IVDs, consultations may focus on performance evaluation plans or high-risk test justifications.

Regulatory Submissions for CE Marking

• Technical Documentation Development and Review: our team prepares and reviews complete technical files in accordance with MDR/IVDR structure and content expectations, including device descriptions, design verification, risk management, manufacturing processes, and benefit-risk justifications.
• Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs): we conduct or support the development of robust CERs and PERs based on current MDCG guidance, incorporating literature reviews, postmarket data, and clinical investigations where applicable. Our team ensures alignment with MEDDEV 2.7/1 rev. 4 (where still relevant) and MDR Article 61 or IVDR Article 56.
• General Safety and Performance Requirements (GSPR) Checklists: we generate and justify conformity with applicable GSPRs, cross-referencing supporting evidence and standards to demonstrate full regulatory alignment.
• Labeling, IFU, and Packaging Review: we review labeling, Instructions for Use (IFU), and packaging content to ensure compliance with language, readability, and content requirements across the EU.
• Declarations of Conformity and Certificates Preparation: our team assists in drafting and reviewing Declarations of Conformity that meet Annex IV expectations and support CE marking issuance.
• Notified Body Engagement and Deficiency Response Support: we liaise with Notified Bodies on your behalf to clarify expectations, manage communication, and respond to deficiencies or nonconformities with scientifically sound, regulator-ready documentation and analysis.
• Clinical Investigation and Performance Study Submissions to Competent Authorities: for high-risk devices or when new clinical data is required, we support the preparation of national submissions for clinical investigation applications to EU Competent Authorities.

ProPharma's team of expert European medical device consultants ensures that your submission is not only technically complete but also strategically aligned with reviewer expectations, reducing the risk of costly delays or non-approvals. Whether you're submitting a new CE application, transitioning from legacy MDD/IVDD compliance, or navigating re-certification under MDR/IVDR, we provide the guidance and hands-on support needed to achieve a successful outcome.

Preclinical and Biocompatibility Testing Strategy

Preclinical testing plays a critical role in demonstrating device safety and performance prior to CE marking. ProPharma develops comprehensive, scientifically sound testing strategies aligned with EU regulatory expectations and international standards.

We support:

• Biocompatibility test planning per ISO 10993
• Electrical safety testing (IEC 60601)
• Software lifecycle validation (IEC 62304)
• Usability engineering and human factors testing (IEC 62366)
• Bench testing and performance simulation
• Risk management file integration (ISO 14971)
• Test protocol and report review for regulatory submission

Our consultants collaborate with certified laboratories and CROs to ensure efficient execution and documentation that will withstand Notified Body review.

EU Reimbursement and Market Access Strategy for Medical Devices and Diagnostics

Our cross-functional team of regulatory, clinical, and health economics experts works with you to ensure that payer expectations are considered early in development and integrated into your regulatory and clinical planning. By combining deep EU regulatory knowledge with local market access insights, we help you achieve both compliance and commercial adoption.

Our EU reimbursement and market access services include:

• Market Access Landscape Assessments: we evaluate reimbursement opportunities and constraints in priority EU markets (e.g., Germany, France, Italy, Spain, Netherlands), identifying specific submission pathways, payer evidence requirements, and market access timelines.
• Health Technology Assessment (HTA) Strategy and Submission Support: we develop and support HTA submissions for key agencies such as eG-BA (Germany), HAS (France), and AIFA (Italy), incorporating clinical and economic data to demonstrate value to payers. We help align CE marking evidence with HTA requirements to reduce duplication and accelerate access.
• Early Access and National Coverage Programs: our team identifies and supports applications for early access schemes, including France's Early Access Program (ex-ATU), Germany’s NUB reimbursement system, and other pilot or conditional coverage mechanisms that may allow market entry before full reimbursement is secured.
• Economic Value Proposition Development: we help manufacturers articulate the clinical, operational, and economic benefits of their technology in a way that resonates with payers, hospital procurement bodies, and other stakeholders. This includes development of core value messages, health economic models, and budget impact analyses.
• Pricing Strategy and Evidence Generation Planning: our experts advise on EU pricing strategies based on local market dynamics, payer expectations, and international reference pricing (IRP) implications. We also help you plan evidence generation activities that support both regulatory and reimbursement success.
• Payer and KOL Engagement: wroPharma supports early and ongoing engagement with payer decision-makers and clinical key opinion leaders (KOLs) across EU countries to shape acceptance and drive adoption.

By building reimbursement planning into your regulatory strategy from day one, we help ensure that your CE-marked device or diagnostic not only reaches the market—but gets adopted, paid for, and used to improve patient outcomes.

Postmarket Surveillance and EU Regulatory Compliance

Our EU postmarket regulatory compliance services include:

• Postmarket Surveillance (PMS) Planning and Reporting: our team of experts can develop or refine PMS Plans in compliance with MDR Article 83 and IVDR Article 78, ensuring they are product-specific, data-driven, and actionable. We also support the generation of PMS Reports (for Class I devices) and Periodic Safety Update Reports (PSURs) for Class IIa and above devices and Class C/D IVDs, ensuring they include trend analysis, benefit-risk updates, and corrective/preventive actions.
• Postmarket Clinical and Performance Follow-Up (PMCF/PMPF): for devices and diagnostics requiring ongoing evidence collection, we design and execute PMCF/PMPF plans and studies per Annex XIV and relevant MDCG guidance. This includes registry development, surveys, observational studies, and literature surveillance—ensuring compliance while minimizing resource burden.
• Vigilance and Incident Reporting: we support timely and compliant reporting of serious incidents and Field Safety Corrective Actions (FSCA) in line with MDR/IVDR timelines and guidance. Our team can manage the end-to-end process, from root cause investigation to Competent Authority communication and Field Safety Notices (FSNs).
• CAPA and Regulatory Audit Support: our team helps identify and resolve compliance gaps through corrective and preventive action (CAPA) planning, internal audits, and readiness assessments for Notified Body surveillance audits or Competent Authority inspections. This includes developing procedures, documentation templates, and training programs to ensure your teams remain inspection-ready.
• Regulatory Intelligence and Lifecycle Monitoring: with regulatory expectations continuing to evolve across EU member states, we provide horizon scanning and regulatory intelligence services to keep you informed of changes affecting your product type, clinical domain, or market strategy. We ensure your postmarket activities adapt accordingly and remain in full compliance.

With regulators placing increasing emphasis on lifecycle data and real-world performance, a strong PMS system is no longer optional—it's foundational. ProPharma helps ensure that your postmarket infrastructure is not only compliant but also a strategic asset for sustaining product performance, protecting patients, and maintaining CE certification under MDR and IVDR.