Medical devices

New References of Harmonized Standards

New references of harmonized standards to the Medical Device Directive 93/42/EEC:

On 25.03.2020, references to harmonized standards were published or withdrawn by implementing decision (EU) 2020/437 (OJ L 90 I, p. 1).Annex I contains 264 reference numbers of harmonized standards relating to the Medical Device Directive 93/42/EEC. This publication has been made for reasons of clarity and legal certainty and constitutes an exhaustive list and replaces the list in Communication 2017/C 389/03 (OJ C 389, 17.11.2017, p. 29). However, it shall continue to apply until 30.09.2021 for the standards listed in Annex II. These 12 standards have been replaced or amended or corrected by new versions and will therefore benefit from a transitional period until they are withdrawn from the Official Journal.In principle, it should be noted that the standards from Annexes I and II may not be used for the presumption of conformity with the requirements of the new Medical Devices Regulation 2017/745, as the requirements differ.For reasons described in more detail in recital 21, this implementing decision is valid until 26.05.2024.

New references of harmonized standards to the Active Implantable Medical Devices Directive 90/385/EEC:

On 25.03.2020, references to harmonized standards were published or withdrawn by implementing decision (EU) 2020/438 (OJ L 90 I, p. 25). Annex I contains 46 references of harmonized standards under the Active Implantable Medical Devices Directive 90/385/EEC. This publication has been made for reasons of clarity and legal certainty and constitutes an exhaustive list replacing the list in Communication 2017/C 389/02 (OJ C 389, 17.11.2017, p. 22). However, it shall continue to apply until 30.09.2021 for the standards listed in Annex II. These 4 standards have been replaced or amended or corrected by new versions and will therefore benefit from a transitional period until they are withdrawn from the Official Journal. In principle, it should be noted that the standards from Annexes I and II may not be used for the presumption of conformity with the requirements of the new Medical Devices Regulation 2017/745, as the requirements differ.For reasons described in more detail in recital 14, this implementing decision is valid until 26.05.2024.

New references of harmonized standards to the Active Implantable Medical Devices Directive 98/79/EC:

On 25.03.2020, references to harmonized standards were published or withdrawn by implementing decision (EU) 2020/439 (OJ L 90 I, p. 33).Annex I contains 41 references of harmonized standards relating to the IVD 98/79/EC. This publication has been made for reasons of clarity and legal certainty and constitutes an exhaustive list and replaces the list in Communication 2017/C 389/04 (OJ C 389, 17.11.2017, p. 62). However, it shall continue to apply until 30.09.2021 for the standards listed in Annex II.

These 3 standards have been replaced or amended or corrected by new versions and will therefore benefit from a transitional period until they are withdrawn from the Official Journal. As a general rule, it should be noted that the standards listed in Annexes I and II may not be used for the presumption of conformity with the requirements of the new Regulation on in vitro diagnostic medical devices 2017/746 as the requirements differ. For reasons described in more detail in recital 10, this implementing decision is valid until 26.05.2024.

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Published on 09.04.2020
Category: Fokus Medical Devices, Standards

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