Implementation model for in vitro diagnostic medical devices regulation : step by step guide : medical devices change of legislation : what you need to know!
Date: 2019-06-09
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Subjects: harmonisation of standards, health legislation, marketing standard, medical device, quality standard, regulation (EU), safety standard, user guide

European 
Commission

Implementation Model for   
in vitro Diagnostic Medical 
Devices Regulation
Step by Step Guide

MEDICAL DEVICES CHANGE OF LEGISLATION
What you need to know!

S T E P

I N T E N T I O N   /   A C T I O N

1

Pre-assessment

2

Gap analysis and actions 
resulting from this

3

Quality Management 
System (QMS)

Brief 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

Assess impact on products, internal resources, organisation and budget

Check new classification rules (IVDR Classes A–D) and confirm conformity assessment 
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)

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 trained

Internal market, 
Industry, 
Entrepreneurship 
and SMEs

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Clarify 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

Do 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)

Build a roadmap for implementation, including definition of sub-projects, resource 
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 transitional 
period, transitional provisions and availability of your Notified Bodies

4

Legal entities

5

Portfolio

Master implementation 
plan

6

7

8

9

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 IVDR implementation and transition workshops

Execute master 
implementation plan

10

Review efficiency and 
effectiveness

Implement the various sub-projects (performance evaluation, technical 
documentation, relations with other economic operators, Unique Device Identification, 
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

Implement 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

11 Notified Body submission

Discuss submission dates to avoid delays in the approval process

12 Ongoing monitoring

Actively 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 risk

20/11/2018

© 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).

Funded under the Third EU Health Programme

ISBN: 978-92-79-89124-3    DOI: 10.2873/41862

https://ec.europa.eu/growth/ 
sectors/medical-devices_en