Answer to Written Question: The Medical Devices Regulation (EU) 2017/745

(Source: European Parliament)

EN

E-001620/2021

Answer given by Ms Kyriakides

on behalf of the European Commission

(31.5.2021)

To place their devices on the market, manufacturers have to ensure that such devices have been designed and manufactured in accordance with the requirements of Regulation (EU) 2017/745[1] on medical devices (MDR). If the device is a reusable surgical instrument[2], the manufacturer has the responsibility to provide information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation.

Conformity assessment procedures for reusable surgical instruments include the involvement of a notified body on aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilisation, maintenance, functional testing and the related instructions for use.

The Commission is working on various implementing acts[3], while specific harmonised standards on information to be provided by the manufacturer for the processing of resterilisable medical devices and on sterilisation processes will be developed within the standardisation requests adopted by the Commission for the MDR[4]. Considering that implementing acts or common specifications may be needed where harmonised standards do not exist, activities related to requirements established in Sections 11.1 and 11.2 of Annex I to the MDR, such as those mentioned in questions two and three, are currently not planned.

In addition, Member States’ competent authorities[5] have the responsibility for market surveillance to ensure that only medical devices compliant with the legal requirements may be placed on the market. The Commission coordinates market surveillance activities through a specific Subgroup of the Medical Device Coordination Group[6].


[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/2020-04-24

[2] ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out (Point 2.3 of Annex VIII to the MDR).

[3] The detailed list of implementing acts can be found in the “Rolling Plan” available on the Commission website, https://ec.europa.eu/health/md_sector/new_regulations

[4] Commission Implementing Decision of 14.4.2021 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council (C(2021) 2406 final), https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=599

[5] Further information on competent authorities on medical devices can be found on the Commission website, https://ec.europa.eu/health/md_sector/contact.

[6] https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=3565

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