MDD vs.

MDR Gap-Assessment Tool Methodology

Methodology of the
MDD vs MDR Gap Assessment Tool:
1. Reduce requirements as much as possible:
a. Remove any chapter and annex that is not applicable e.g
i. Chapter IV – Notified Bodies
ii. Annex VII – Requirements to be met by Notified Bodies
iii. Annex X – Conformity based on type examination
iv. Annex XI – Conformity based on product conformity verification
v. Annex XIII – Procedure for custom-made devices

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b. Remove requirements with the search function.

Use keywords which do not affect your products. See below for
examples of keywords.

Keywords
Sterile Implant Class I
Class IIa Class IIb Class III
Active device Custom-made devices Medicinal
Drug Food Cosmetic
In vitro diagnostic Software Single use device
Transplant Radiation Tissue
e.g e.g e.g

Note: Before deciding 'Not Applicable', make sure that all Applicable keywords
are not included in that paragraph.

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2. Continue making selections from the economic operators drop

down menu to look for the applicable requirements.

3. Go to the rest of content and decide whether it's applicable or

not for the paragraph in column J (Required for your Company?).

Once this is complete, this is the scope of the assessment.

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4. Once the scope is fixed, go to the column D

(correlation) and select “correlation” to see the factual
changes and updates to comparable paragraphs to the
MDD, and direct changes from MDD to MDR.

Start with the GAP assessment, with the most relevant

chapters like:
a. Classification
b. Clinical Evaluation
c. Conformity Assessment
d. General safety and performance requirements
e. Technical documentation

4a. Paragraphs with ‘Correlation’ mean the paragraphs and

wording are comparable between the MDD and MDR;
you should be in compliance to the MDD already, so
the ‘Wording Gap-Analysis‘ (column C) will highlight the
factual changes to the MDR. Since the MDD text (column B)
is included, you can check both paragraphs.

4b. Although the paragraphs with ‘Correlation in

Scope’ cover the same topic or requirement, the
wording between them has a significant change and it is
not possible to compare it. For these and ‘No Correlation’,
it is recommended to start from scratch, and analyze
paragraphs one by one from MDR perspective.

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5. Assign departments and gaps and start the actions to

complete the project.

For more information, please contact us:

Michael Galliker: Michael.galliker@regulatoryglobe.com

or:
Ivan Perez Chamorro: ivanp@medboardco.com

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