CLASS I MDD DEVICES: HOW TO BENEFIT FROM THE TRANSITIONAL PERIODS OF ARTICLE 120(3) MDR
EPUBLICATION
27 APRIL 2020
Article 120 MDR allows for some class I MDD devices to be placed on the market beyond 26 May 2020 without having to comply with all requirements of the MDR. However, the relevant provisions are quite complex. Our ePublication attempts to provide some guidance on the conditions and steps to be taken by manufacturers in order to benefit from the relevant transitional periods.
HOW (AND WHICH) CLASS I MDD MEDICAL DEVICES CAN BENEFIT FROM THE ARTICLE 120 MDR TRANSITIONAL PERIODS
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BACKGROUND
The (partly amended) provisions of art. 120 pars. 3 and 4 of EU Regulation 2017/745 (the «MDR») allow, under certain conditions, for some class I medical devices to be placed or made available on the market or be put into service until 26 May 2024, or 26 May 2025 respectively, i.e. for periods exceeding the date of application of the MDR (which is 26 May 2021). However, the relevant provisions are rather complex.
Given this particular background, the MDCG has, in March 2020, issued a document (no. 2020-2; «Class I Transitional provisions under Article 120 (3 and 4) – (MDR)») that aims at providing guidance on how manufacturers of some of the devices concerned can make efficient use of the provisions of art. 120 pars. 3 and 4 MDR. Yet, the information and representations contained in this document appear, in part, somewhat ambiguous and inconsistent and thus not entirely helpful with regard to clarifying the overall situation.
In the light of this, our ePublication attempts to provide some guidance, from a more holistic perspective, on the specific conditions and steps to be taken by manufacturers in order to benefit from the transitional period provided for by art. 120 MDR. It is accompanied by a flowchart outlining, in a simplified manner and as a «quick overview», the contents of the ePublication paper.