Medisinsk utstyrsforordningen 2017: gjennomføringsbestemmelser om sikkerhetskrav til produkter med ikke-medisinsk formål

Tittel

(Utkast) Kommisjonens gjennomføringsforordning om fastsettelse av spesifikasjoner for produktgrupper med ikke-medisinsk formål oppført i vedlegg XVI til europaparlaments- og rådsforordning (EU) 2017/745

(Draft) Commission Implementing Regulation laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

Siste nytt

Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 18.10.2022

Nærmere omtale

BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)

(1) Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. Regulation (EU) 2017/745 further requires the Commission to adopt for groups of products without an intended medical purpose listed in its Annex XVI, common specifications addressing, at least, application of risk management as set out in the general safety and performance requirements laid down in Annex I to that Regulation and, where necessary, clinical evaluation regarding safety.

(2) From the date of application of the common specifications, Regulation (EU) 2017/745 is to apply also to those groups of products without an intended medical purpose.

(3) In order for manufacturers to be able to demonstrate the conformity of products without an intended medical purpose with regard to application of risk management, the common specifications should cover the application of risk management as set out in the second sentence of Section 1 and in sections from 2 to 5, 8 and 9 of Annex I to Regulation (EU) 2017/745. Consequently, in accordance with Article 9(2) of Regulation (EU) 2017/745, products without an intended medical purpose that are in conformity with the common specifications are to be presumed to be in conformity with the requirements set out in those provisions.

(4) The common specifications should in principle be laid down for all groups of products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745. However, as Regulation (EU) 2017/745 regulates the placing on the market, making available on the market or putting into service in the Union, common specifications are not needed for products for which there is no information available about them being marketed in the Union. For example, there is no information on the following products being marketed in the Union: contact lenses containing tools, such as antenna or microchip, contact lenses which are active devices; active implantable products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixing a part of the body; active devices intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction; active implantable equipment intended to be used to reduce, remove or destroy adipose tissue. In addition, for some products the information available is not sufficient to allow the Commission to draw up common specifications. That is for example the case for some other items intended to be introduced into or onto the eye.

(5) Sunbeds and equipment using infrared optical radiation to warm the body or parts of the body intended for treatment of tissues or parts of the body under the skin should not be considered products for skin treatment for the purposes of Annex XVI to Regulation (EU) 2017/745. Consequently, they should not be covered by this Regulation.

(6) The group of products listed in point 6 of Annex XVI to Regulation (EU) 2017/745 is intended for brain stimulation where only electrical currents or magnetic or electromagnetic fields penetrate the cranium. Invasive devices intended for brain stimulation, such as electrodes or sensors that are partially or totally introduced into the human body, should not be covered by this Regulation.

(7) Regulation (EU) 2017/745 requires a product without a medical purpose listed in Annex XVI to that Regulation, when used under the conditions and for the purposes intended, to present no risks at all or present a risk that is no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons.

(8) The groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 cover a wide variety of devices for different applications and intended uses. A common methodology for risk management should be drawn up to ensure a harmonised approach by manufacturers of different groups of devices and to facilitate a coherent implementation of the common specifications.

(9) In order to ensure appropriate risk management, it is necessary to identify specific risk factors to be analysed and minimised and to identify specific risk control measures to be implemented with respect to each group of products listed in Annex XVI to Regulation (EU) 2017/745.

(10) In order to facilitate the implementation of risk management by manufacturers of both medical devices and products without an intended medical purpose risk management for both groups of products should be based on the same harmonised principles and the requirements should be compatible. The rules on the application of risk management should therefore be in line with well-established international guidance in the field, including the international standard ISO 14971:2019 on application of risk management to medical devices.

(11) Regulation (EU) 2017/745 provides that the clinical evaluation of products without an intended medical purpose are to be based on relevant clinical data concerning performance and safety. Such data are to include information from post-market surveillance, post-market clinical follow-up, and, where applicable, specific clinical investigation. As in general it is not possible to demonstrate equivalence between a medical device and a product without an intended medical purpose, where all available results on clinical investigations relate to medical devices only, clinical investigations should be performed for products without an intended medical purpose.

(12) Where clinical investigations are performed to confirm the conformity with the relevant general safety and performance requirements, it is not possible to complete the clinical investigations and the conformity assessment within six months. For such cases transitional arrangements should be laid down.

(13) Where a notified body has to be involved in the conformity assessment procedure, it is not possible for the manufacturer to complete the conformity assessment within 6 months. For such cases transitional arrangements should be laid down.

(14) Transitional provisions should be laid down also for products covered by Annex XVI to Regulation (EU) 2017/745 for which notified bodies have issued certificates in accordance with Council Directive 93/42/EEC . Also for those products, it is not possible for the manufacturer to complete clinical investigations and the conformity assessment within 6 months.

(15) In order to ensure the product safety during the transitional period, it should be allowed to continue to place the products on the market and to make them available on the market or put them into service, provided that the products in question were already lawfully marketed in the Union before the date of application of this Regulation, that they continue to comply with the requirements of Union and national law applicable before the date of application of this Regulation and that their design and intended purpose are not significantly changed. As the purpose of putting in place the transitional arrangements is to allow the manufacturers enough time to conduct the required clinical investigations and conformity assessment procedures, the transitional arrangements should cease where manufacturers do not proceed with the clinical investigations or conformity assessment procedure, as applicable, within a reasonable timeframe.

(16) The Medical Device Coordination Group has been consulted.

(17) The application date of this Regulation should be deferred as provided for in Regulation (EU) 2017/745.

(18) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices

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Dokument (forberedende)
Kommisjonens framlegg
Dato
18.10.2022

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