지침,참고문헌 | MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

MDCG 2020-2 Class I Transitional provisions under Article.pdf (898.9K) [41]

How can affected manufacturers of some class I devices1 make efficient
use of the transitional provisions in Article 120 (3) and (4) of Regulation
(EU) 2017/745 – Medical Devices Regulation (MDR)?
Background:
The corrected MDR2 Article 120 (3) allows under certain conditions, some class I devices pursuant to
Directive 93/42/EEC – Medical Devices Directive (MDD), for which the Declaration of Conformity
was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to
the MDR would require the involvement of a notified body, to be placed on the market3 until 26 May
20244.
In order to make use of this article, the following conditions must be met:
1. The device continues to comply with Directive 93/42/EEC,
2. A notified body will need to be involved under the MDR (e.g. re-usable surgical instruments or
up-classified devices)
3. A valid Declaration of Conformity, according to Annex VII of the MDD, must be drawn up
before 26 May 2020,
4. No significant changes to the design or intended purpose of the device after 26 May 20205,
5. The requirements of the MDR relating to post-market surveillance, market surveillance,
vigilance, registration of economic operators and of devices shall apply in place of the
corresponding requirements in Directive 93/42/EEC.6 This shall be in place on the 26 May 2020.
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