Regulatory

Through selling to a global market we have dealt with the complexity of global regulatory requirements. We are an FDA registered organisation and have obtained FDA 510k approval for our own products and are fully conversant with the requirements to release products into specific markets.

Duckworth & Kent is committed to quality and the continuing improvement of product and Quality Management System to meet customer and global regulatory requirements.

The quality policy includes achieving customer satisfaction through good insight in our customer’s requirements as well as the evaluation of information relating to the customer perceptions as to whether Duckworth & Kent has met the customer requirements.

Certificates

ISO 9001:2015

ISO 13485:2016

CE (93/42/EEC) 2 Certificates

Duckworth & Kent Ltd. complies with international regulatory requirements and is certified for:

ISO-9001:2015
ISO-13485:2016
Medical Devices Directive 93/42/EEC
and is FDA registered

Duckworth & Kent first obtained international certification of its Quality Management System in January 1996 under ISO 9001 and EN46001. At the same time, it introduced CE marking of its medical devices under the Council Directive 93/42/EEC.

In addition, in 1998 Duckworth & Kent was assessed and certified to the requirements of ISO13485.
In September 2004 Duckworth & Kent’s Quality Management System was updated to conform to the requirements of ISO 9001:2000 and ISO13485:2003

Currently Duckworth & Kent is certified to ISO 9001:2015 and ISO 13485:2016 and are in conformance with the Council Directive 93/42/EEC as amended by Council Directive 2007/47/EC.

Within Duckworth & Kent’s product range are devices that are classed as ‘Investigational Devices’. These devices may not be available for sale in certain countries where the product has not yet received marketing or clinical approval. For further information about any investigational devices and their availiblity please contact us.

Our Directive Certificates have changed as of 16.12.19

In preparation for the UK leaving the European Union on the 31st January 2020, with a transition period extended until 31st December 2020 (as per European Union Agreement 2019/C3841/01), our Notified Body SGS have transferred our Directive 93/42/EEC (CE Mark) certificates that cover our Class IIA Irrigation and Aspiration devices and our Class Im Measuring devices from the UK to Belgium, to ensure that our certificates continue to be held within the European Union. This means that our Notified Body number has now changed from 0120 (UK) to 1639 (Belgium).

In accordance with our certificate migration agreement, please note that there is an official six month label transition period as of 16th December 2019 which allows a manufacturer to continue to supply devices marked with the old Notified Body number (0120) into the market place. This label transition period will end on the 16th June 2020.

Any Distributors that are currently holding CE0120 stock of our devices or have any of these devices within their supply chain are not affected by this label transition period, as these devices are considered to have already been “placed on the market” in accordance with EU regulations.