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.

Certificates

We are committed to quality and the continuous improvement of products and Quality Management Systems to meet customer and global regulatory requirements.

The quality policy includes achieving customer satisfaction through good insight into 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 13485:2016

CE (93/42/EEC) 2 Certificates

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

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.

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

EU DECLARATIONS OF CONFORMITY

EU Declarations of Conformity (DoC) are formal statements by Duckworth & Kent as the manufacturer, confirming that our products meet EU standard 93/42/EEC. This declaration is necessary for affixing the CE mark and selling our product in the European Economic Area (EEA).

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MANUFACTURER’S DECLARATION

In relation to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, in particular with
respect to

• the validity of certificates issued under Council Directive 90/385/EEC on Active Implantable Medical
Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MOD) (Directive Certificates)
and/or1

• the compliance of the devices and us as their manufacturer with the conditions for the continued
placing on the market and putting into service

Manufacturer's Declaration - Signed PDF

Confirmation Letter Reference CLNB1639 – GBPC 04406

This letter confirms that, SGS Belgium NV, a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number 1639 on NANDO, has received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the
following manufacturer:

Duckworth & Kent Ltd
Terence House
7 Marquis Business Centre
Royston Road
Baldock
Hertfordshire
SG7 6XL
UK
SRN: GB-MF-000002176

Authorised Representative:
Emergo Europe
Westervoortsedijk 60
6827 AT Arnham
The Netherlands
SRN: NL-AR-000000116

Confirmation Letter Reference CLNB1639 - GBPC 04406