MEDICAL DEVICES  CHANGE OF LEGISLATION
Internal market, 
Industry,  
Entrepreneurship  
and SMEs1STEP  INTENTION / ACTION
Pre-assessmentBrief management to ensure a clear understanding of the importance and  
business implications of the IVDR
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 (IVDR Classes A–D) and confirm conformity assess -
ment routes for existing and future products. Check the requirement for involving the 
Notified Bodies
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 56)
Review product labelling (Annex I Chapter III)
Ensure post-market surveillance (PMS) arrangements are adequate (Chapter VII 
Section 1)
Prepare a post-market performance follow-up plan (PMPF, Annex XIII 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 IVDs 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!Implementation Model for
In-Vitro Diagnostic Medical 
Devices Regulation  
Step by Step Guide
Ref. Ares(2018)3873813 - 20/07/20182Legal 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 related 
to the new risk classification system and the need of involving a Notified Body 
and costs for post-market surveillance and gaps in the technical documentation, 
and plan your transition to the IVDR 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, re -
source requirements and a steering group, and ensure overall responsibility for 
IVDR implementation has been established
Give special consideration to certificate expiry dates, bearing in mind the transi -
tional 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 IVDR implementation and transition workshops
Execute master  
implementation planImplement the various sub-projects (performance evaluation, technical  
documentation, relations with other economic operators, Unique Device Identifica -
tion, labelling, 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 IVDR 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 IVDR 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 IVDR 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).
ISBN: 978-92-79-89124-3    DOI: 10.2873/41862
ET-04-18-659-EN-N