Europe Regulatory

Our Experience in European Regulatory

MCRA is Europe's leading regulatory advisor for medical devices and in-vitro diagnostic medical devices. The European Regulatory team brings direct industry, Notified Body and Competent Authority experience, across a wide range of device technologies, classifications and novelty. Our in-depth knowledge and combined decades of experience provides access to extensive regulatory guidance and unparalleled expertise in European regulatory affairs.

• Ad-hoc or fully integrated Consultancy: A full-service regulatory consultancy offering support throughout the product lifecycle, from initial design to market approval (CE mark, UKCA mark) and post-market activities. At any stage of the development cycle, the MCRA team can provide technical and regulatory expertise to expedite development projects and drive successful market entry and compliance. This support can be either ad-hoc, phased or fully integrated with our other services, to suit your requirements. Our European Regulatory expertise is integrated into our Clinical Affairs service to ensure MCRA has the capability to fully assess clinical evidence requirements and, if needed, directly generate the clinical data to meet evidentiary and regulatory requirements.

• Our Expertise: Former Notified Body and Competent Authority highly experienced technical and regulatory experts provide direct insight into the European regulatory systems, optimizing success and mitigating development risks. State of the art knowledge and continuous evolution ensure our experts remain at the leading edge of regulatory expertise.

• Global Approach: Our global regulatory approach integrates European regulatory requirements with core geographies such as the United States, Japan, Canada, Australia and multiple other global markets. 

• Tailored Training: MCRA can leverage our depth of expertise into tailor-made training programs, empowering technical, regulatory and clinical teams within your organization to deliver on bringing innovative medical devices to market faster.

MCRA's European team is led by former Notified Body regulators with extensive experience in medical device and IVD regulation in the EU, UK and Switzerland covering a wide and diverse array of medical technologies.

MCRA provides our clients with the best representation in demonstrating the science, safety, and efficacy of their technologies, driving successful market approvals, with the highest standards of compliance and patient safety.

Regulatory Strategy

MCRA can provide regulatory strategic services at any point during the regulatory process. Services include:

• Strategy and regulatory pathway assessments outlining the critical regulatory considerations specific to your product.

• Develop comprehensive strategies and timelines (e.g., global registration plan) for the introduction of devices to global markets throughout the product life-cycle.

• Continuous support including communications and meetings throughout the process provided by subject matter experts.

• MCRA-led training for your team on regulatory expectations, requirements, and processes.

Technical Documentation

MCRA can assist with development, writing and/or reviewing your technical documentation for submission to a specified regulatory body. We can integrate into your processes and develop documentation per your procedures, or MCRA services can include document building based on MCRA-developed templates. MCRA technical documentation services include:

• Perform a thorough review of current Technical Documentation to identify gaps in the submission documentation and evidence.

• Develop, create, and review scientific, clinical/performance and technical documents.

• Implement current and upcoming standards, regulations, and requirements into your Technical Documentation, including state of the art gap assessments and remediation strategies.

• Review, strategize and develop responses to regulatory body questions based on MCRA's technical expertise and experience with similar technologies.

• Assist with maintaining the technical documentation including regular updates, design changes, post-market surveillance activities, or re-certification. 

• Review product labeling, including IFU, device labels, and promotional materials for completeness and market compliance.

• Develop and review UDI compliance.

• Prepare and manage UDI/Device data submissions to EUDAMED. Develop compliant risk management procedures including risk management plans and risk analysis in compliance with ISO 14971.

Clinical Evaluation for Medical Devices / Performance Evaluation for IVDs

MCRA can assist with development, writing and reviewing of your Clinical/Performance Evaluation Report (CER / PER) for submission to a specified regulatory body. MCRA clinical/performance evaluation services include:

• Procedures for Clinical Evaluation / Performance Evaluation - Create compliant procedures related to the Planning of Clinical/Performance Evaluation (CEP/PEP), development of the CER/PER, conducting literature reviews, and data appraisal methodology, and link to procedures for post-market surveillance.

• CER/PER Strategic Planning - Perform an analysis of available data to determine what is required to meet the regulatory level of sufficiency; this includes an assessment of pre-market investigation data and/or existing post-market data; assist with assessing large product portfolios for strategic placement of devices within the Technical Documentation and CER/PER.

• CER/PER Drafting - Develop and update clinical/performance evaluations in compliance with MDR or IVDR and MDCG guidance, as well as reports for other worldwide markets. MCRA can develop the entire CER/PER or specified sections. For MDR, this can include equivalence justifications, clinical investigation summary, literature review (see below), post-market data assessment and summary, and benefit-risk assessment. For IVDR, this can include the Scientific Validity Report, Analytical Performance Report and/or Clinical Performance Report, literature review (see below) as required, and summaries, including overall benefit-risk assessments.

• Comprehensive Literature Reviews - MCRA can perform comprehensive literature reviews including database searches and safety and performance analyses, covering the state of the art, similar devices, and subject device(s).

• Evaluation of Clinical Evidence - As part of the CER/PER development, MCRA will evaluate your clinical evidence for data sufficiency to demonstrate conformity with the relevant General Safety and Performance Requirements or other key regulatory benchmarks. MCRA will assess all data sources to generate a benefit risk assessment to determine the benefit risk profile of the device; whether any actions are required post-market, and ultimately, support market entry for the device.

Technical Documentation for Post-Market Surveillance/PMCF/PMPF

• Develop robust, integrated Post-Market Surveillance (PMS) programs, interfacing with clinical/performance data, risk management and state of the art post-certification.

• Strategize the process inputs and outputs across your PMS program, risk management, and CER/PER ensuring continuous review and alignments of benefit risk and compliance.

• Generate any required Summary of Safety & Clinical Performance (SSCP) or IVD Summary of Safety and Performance (SSP).

• MCRA can support implement PMS and post-market clinical follow-up (PMCF) or IVD post-market performance follow-up (PMPF) requirements, including procedures and templates for plans and reports.

• Navigate reporting requirements per MDR or IVDR (e.g., incident reportability, EUDAMED requirements, SSCP/SSP, Periodic Safety Update Reports (PSUR) or Post-Market Surveillance Reports.

UKCA Mark

With the UK leaving the EU, the UK currently follows the Medical Device Directives (as UK MDR 2002). A UK Approved Body will be needed to perform your conformity assessment for a UKCA mark. While there is a lot of overlap in the requirements in the UK and EU, this certification process is rapidly evolving. MCRA can help you navigate the regulatory considerations for assessment in the UK, along with the EU market, including identification of Approved Bodies for your conformity assessment.

Our Locations

MCRA is established in the leading European medical device markets of the European Union, United Kingdom and Switzerland.