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EU MDR Compliance Services
In the European Union (EU), medical device companies are required to meet stringent requirements and obtain ConformitƩ EuropƩenne (CE) certification, according to EU Medical Device Regulation (EU MDR) 2017/745. Pharma Wizard has expertise in EU MDR compliance services, aiding medical device manufacturers in meeting intricate requirements in a timely manner.
EU MDR Compliance Services Overview
The EU Medical Device Regulation (MDR) officially took effect on 26th May 2021, following a 3-year transition period and a one-year COVID-19-related extension. Any new medical devices entering the EU market must now fully comply with these updated regulations and obtain CE certification through Notified Bodies authorized under EU MDR. Devices that were already CE marked under the older EU MDD regulations have been granted grace periods before mandatory MDR compliance. During this transition, products certified under both EU MDD and EU MDR will coexist in the market with equal regulatory standing. Pharma Wizard delivers unmatched EU MDR compliance solutions, helping manufacturers meet all regulatory obligations efficiently and on time.
Transition Timeline and New Device Classifications
As of May 2021, the MDR is fully enforceable across all EU member states and EFTA countries. It provides manufacturers with a 4-year window to complete the transition and obtain full EU MDR certification.
The new European Medical Device Regulation (MDR), as observed, have also brought changes to existing device classification system such as:
From identifying precise regulatory updates to executing them effectively, manufacturers must overcome a range of challenges to align with EU MDR requirements. Whether it’s interpreting the revised framework, correctly classifying a device, or compiling and submitting comprehensive documentation, a more thorough and cross-functional Regulatory strategy is essential to meet the expectations of the new European Medical Device Regulations. Through a rigorous gap analysis, Pharma Wizard supports clients in assessing their current compliance status and outlines the critical Regulatory actions required for a successful EU MDR transition.
EU MDR Compliance Services
- Expertise
- Creating a clear and actionable strategy for implementing the Medical Device Regulation (MDR)
- Gaining a full understanding of the updated legislation and conducting Gap Analysis against current Quality Management Systems (QMS) and procedures
- Building a detailed, cross-functional plan to identify which parts of the QMS need to be updated in line with the new EU MDR
- Establishing dedicated teams within the organization for product scope assessment, device classification, QMS management, and assigning a single point of contact per team
- Planning and allocating resources efficiently to meet compliance goals
- Reviewing how your QMS aligns with other global regulations and using this opportunity to enhance workflows and future-proof operations
- Evaluating existing test data and identifying any new requirements introduced by the MDR
- Aligning expectations and coordinating your transition strategy with EU Notified Bodies
- Performing thorough Gap Analysis for devices transitioning from EU MDD to EU MDR
- Full-cycle support for developing Clinical Evaluation Reports (CER), including literature reviews per EU MDR standards
- Comprehensive services for Post-market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSUR), and Summary of Safety and Clinical Performance (SSCP)
- Providing Regulatory Resource Augmentation, with both onsite and remote engagement models
- Acting as a European Authorized Representative (EAR) where needed
- Assisting with MDR compliance and submission procedures for Notified Bodies
- Delivering Regulatory Intelligence services, including guidance on import processes across regulated regions
- Supporting QMS audits and readiness through mock audit sessions
- Offering tools and systems for effective document management tailored to MDR needs
- Supporting device classification and reclassification based on risk categories
- UDI (Unique Device Identification) implementation and advisory services
- Post-market Surveillance support compliant with MDR
- Consulting on Risk Management aligned with ISO 14971
- Hosting in-house and online training programs
- Services to designate and assist the Person Responsible for Regulatory Compliance (PRRC)
- Helping identify and coordinate with the right MDR-accredited Notified Bodies
