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MD MFR Stepbystep

Step-by-step guide on the implementation of a class 1 medical device

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9 views2 pages

MD MFR Stepbystep

Step-by-step guide on the implementation of a class 1 medical device

Uploaded by

bbotje2
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Implementation Model for

Medical Devices
Regulation
Step by Step Guide

MEDICAL DEVICES CHANGE OF LEGISLATION


What you need to know !

STEP INTENTION / ACTION


Brief management to ensure a clear understanding of the importance and
business implications of the MDR
1 Pre-assessment Consider organisational challenges: management awareness,
staffing capability and availability, budget implications

Assess 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)


GAP analysis and actions
2 Check the adequacy of available clinical evidence and risk
resulting from this 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)

Review adequacy of QMS to meet standards and processes for medical devices
under the new Regulation

3 Quality Management Build new regulatory requirements into the QMS


System (QMS)
Identify/hire the person responsible for regulatory compliance within your
organisation (Article 15) and be sure it is adequately qualified and trained

1
Internal market,
Industry,
Entrepreneurship
and SMEs
ET-03-18-103-EN-N
Clarify how the company is affected: legal entities, obligation of economic
operators, organisational structures and resources

4 Legal entities 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 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
5 Portfolio 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)

Build a roadmap for implementation, including definition of sub-projects,


resource requirements and a steering group, and ensure overall responsibility for
Master MDR implementation has been established
6
implementation plan 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
7 Notified Bodies availability to service the implementation plan

8 Regulatory training Empower and train staff through MDR implementation and transition workshops

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)
Execute master Ensure a cross-functional project management team is in place to cover all
9 implementation plan aspects of implementation

Ensure overall and individual responsibilities for MDR implementation have been
established

Implement regular meetings on project status and progress, discrepancy and


Review efficiency and gap analyses, risks, next steps and requirements
10
effectiveness Hold regular progress reviews against the MDR implementation plan and include
these in the management review process

11 Notified Body submission Discuss submission dates to avoid delays in the approval process

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)
12 Ongoing monitoring Establish a procedure for dealing with unannounced inspections from Notified Bodies

Regularly review the MDR implementation plan, identifying and addressing key
areas of risk

© 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).
2
ISBN: 978-92-79-89702-3 DOI: 10.2873/66341

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