This document is composed of one unique form with 7 sections.

We ask that you carefully review each of these sections to ensure that you have completed the element(s) applicable to your company's transition plan

 

Sections

 

1 General information

Applicable to everyone

2 Existing certification

Applicable to everyone

3.Class I reusable

Only applicable to manufacturers who intend to put on the market after May 26, 2020 at least one Class 1 Reusable surgical instrument subject to an initial certification under the (EU) 2017/745 implying the intervention of a Notified Body

4. Upclassified Class I

Only applicable to manufacturers who have Class I medical device(s) under Directive 93/42/EEC subject to an initial certification under the EU MDR 2017/745 because of the upgrade of its classification

5. Timeline MDR Option A

Only applicable to manufacturers who plan to transition all devices AT ONCE

6. Timeline MDR Option B

Only applicable to manufacturers who plan to transition all devices GRADUALLY

7.Timeline MDR Option C

Only applicable to manufacturers who plan to request certification of devices not sold onto the European Market yet or Certified by another Notified Body

 

 

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