Guidance for EU MDR 2017/745 – Reusable Medical Devices (Class Ir)

Guidance for EU MDR 2017/745 – Reusable Medical Devices (Class Ir)

£160.00

The new European medical device regulation, EU MDR 2017/745 has seen the introduction of a new subclass of Class I devices covering reusable surgical devices and the reprocessing of single-use devices for sale on the European market.

This guidance document aims at helping manufacturers determine the classification of their device; provide a reference to the broader MDR; understand the requirements of their device regarding conformity and the documentation supplied with the device.

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Description

The new European medical device regulation, EU MDR 2017/745 has seen the introduction of a new subclass of Class I devices covering reusable surgical devices and the reprocessing of single-use devices for sale on the European market.

This guidance document aims at helping manufacturers determine the classification of their device; provide a reference to the broader MDR; understand the requirements of their device regarding conformity and the documentation supplied with the device.

A selection of examples are included to show how the Class Ir applies to a range of devices.

Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.

Our consultants are available, should you need further assistance in completing the documentation.