footsteps towards a sign saying ce, symbolizing step by step guide to EU CE medical device certification

Medical Device Certification Based on the New EU MDR: a Step by Step Guide

Medical devices are strictly regulated and for good reason. Patients should benefit from safe and useful technology and not be harmed. For this reason, manufacturers must have their medical devices certified if they want to market them in Europe. However, medical device certification is now based on the new EU MDR, the EU Medical Device Regulation (2017/745/EU), which came into force in May 2018. This confronts manufacturers with a number of new challenges. Use this step-by-step guide to prepare yourself practically and in time for the transition period.

Pre-Assessment

  • brief your management to ensure a clear understanding of the importance and business implications of the EU MDR
  • consider organizational challenges: management awareness, staffing capability, staffing availability and budget implications

GAP Analysis and Actions

  • assess the impact on products, internal resources, organization and budget
  • check new classification rules (EU MDR classes I, IIa, IIb and III)
  • confirm the conformity assessment routes for existing and future products
  • check the new definition of medical devices, particularly with respect to its expanded scope (this also applies to products covered in Annex XVI)
  • review the changes needed to existing technical documentation (technical files)
  • review and upgrade quality management system (see following section)
  • review available clinical evidence and risk management information and identify any gaps (Article 61)
  • review product labelling (Annex I Chapter III)
  • check the new requirements of the unique device identification (UDI) system (Article 27)
  • ensure that post-market surveillance arrangements are adequate (Chapter VII Section 1)
  • prepare a post-market clinical follow-up plan (Annex XIV Part B)
  • get ready for the new vigilance requirements (Chapter VII Section 2)
  • ensure the respect of traceability obligations (Chapter III)

Quality Management System

  • review the quality management system to meet standards and processes for medical devices under the new regulation
  • build new regulatory requirements into the quality management system
  • identify and hire the person responsible for regulatory compliance within your organization (Article 15)
  • be sure that the person responsible for regulatory compliance is adequately qualified and trained

Legal Entities

  • clarify how the company is affected: legal entities, obligation of economic operators, organizational structures and resources
  • consider organizational challenges: management awareness, staffing capability and availability, budget implications
  • ensure product liability insurance is adequate

Portfolio

  • do a cost/benefit analysis for your product portfolio
  • take into account costs for the possible upgrade of risk class of medical devices and for the new procedures for conformity assessment
  • consider costs for possible post-market surveillance and gaps in the technical documentation and plan your transition to the EU MDR accordingly
  • review supply chain provisions
  • clarify roles and responsibilities of business partners (authorized representatives, importers, distributors)

Implementation Plan

  • build a roadmap for implementation, including definition of sub-projects, resource requirements and a steering group
  • ensure overall responsibility for EU MDR implementation has been established
  • give special consideration to certificate expiry dates, bearing in mind the transitional period, transitional provisions and availability of your Notified Bodies
  • contact the selected Notified Bodies and determine their capacity and availability to service the implementation plan

Regulatory Training

  • empower and train staff through EU MDR implementation and transition workshops

Implementation

  • implement the various sub-projects (clinical evaluation, technical documentation, relation with other economic operators, unique device identification, labelling, registration, post-market surveillance, vigilance, and reporting IT systems)
  • ensure a cross-functional project management team is in place to cover all aspects of implementation
  • ensure overall and individual responsibilities for EU MDR implementation have been established

Review Efficiency and Effectiveness

  • implement regular meetings on project status and progress, discrepancy and gap analyses, risks, next steps and requirements
  • hold regular progress reviews against the EU MDR implementation plan and include these in the management review process

Notified Body Submission

  • discuss submission dates to avoid delays in the approval process

Ongoing Monitoring

This factsheet is based on the publication by the EU Commission from 2018 (Step by step implementation model for medical devices regulation, ISBN:978-92-79-89702-3 DOI: 10.2873/66341). 

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