Implementation Model for
Medical Devices  
Regulation  
Step by Step Guide
MEDICAL DEVICES  CHANGE OF LEGISLATION
1STEP  INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and  
business implications of the MDR
Consider organisational challenges: management awareness,  
staffing capability and availability, budget implications
GAP analysis and actions  
resulting from thisAssess impact on products, internal resources, organisation and budget
Check new classification rules (MDR Classes I, IIa, IIb and III) and confirm conformity 
assessment routes for existing and future products
Check the new definition of MD, 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 (QMS) (point 3 below)
Check the adequacy of available clinical evidence and risk  
management and identify any gaps (Article 61)
Review product labelling (Annex I Chapter III)
Ensure post-market surveillance (PMS) arrangements are adequate (Chapter VII 
Section 1)
Prepare a post-market clinical follow-up plan (PMCF, 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 (QMS)Review adequacy of QMS to meet standards and processes for medical devices 
under the new Regulation
Build new regulatory requirements into the QMS
Identify/hire the person responsible for regulatory compliance within your  
organisation (Article 15) and be sure it is adequately qualified and trained1
2
3What you need to know!
Internal market, 
Industry,  
Entrepreneurship  
and SMEs2Legal entitiesClarify how the company is affected: legal entities, obligation of economic  
operators, organisational structures and resources
Consider organisational challenges: management awareness, staffing capability 
and availability, budget implications
Ensure product liability insurance is adequate
PortfolioDo a cost/benefit analysis for your product portfolio; bear in mind costs for the 
possible upgrade of risk class of MDs and for the new procedures for conformity 
assessment as well as the costs for post-market surveillance and gaps in the 
technical documentation, and plan your transition to the MDR accordingly
Review supply chain provisions, and clarify roles and responsibilities of business 
partners (authorised representatives, importers, distributors)
Master  
implementation planBuild a roadmap for implementation, including definition of sub-projects,  
resource requirements and a steering group, and ensure overall responsibility for 
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
Notified BodiesContact the selected Notified Bodies and determine their capacity and  
availability to service the implementation plan
Regulatory trainingEmpower and train staff through MDR implementation and transition workshops
Execute master  
implementation planImplement 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 MDR implementation have been 
established
Review efficiency and  
effectivenessImplement regular meetings on project status and progress, discrepancy and 
gap analyses, risks, next steps and requirements
Hold regular progress reviews against the MDR implementation plan and include 
these in the management review process
Notified Body submissionDiscuss submission dates to avoid delays in the approval process
Ongoing monitoringActively monitor the still-developing European regulatory environment and 
guidelines expected in the coming months (check DG GROW web pages on  
medical devices and subscribe to the newsletter)
Establish a procedure for dealing with unannounced inspections from Notified Bodies
Regularly review the MDR implementation plan, identifying and addressing key 
areas of risk4
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© European Union, [2018]  Reuse is authorised provided the source is acknowledged.
The reuse policy of European Commission documents is regulated by Decision 2011/833/EU (OJ L 330, 14.12.2011, p. 39).
ET-03-18-103-EN-N
ISBN: 978-92-79-89702-3    DOI: 10.2873/66341