Dear Sir/Mam,

Can you please advise whether medical goods not having a CE mark are allowed to be purchased by hospitals?

Can you please, let us know whether the device(s) manufactured by the manufacturer stated below is allowed to be used in European Union countries?

Address: H.W. Andersen Products, Inc.
Health Science Park
3202 Caroline Dr.
Haw River, NC 27258-8710
USA

Products: EOGas Series 3 Plus (ethylene oxide sterilizer with machine and all the consumables CE marked and EPA registered)

Anprolene Table Top Gas Sterilizers (ethylene oxide sterilizer with machine and all the consumables CE marked and EPA registered)

Additionally, as far as we have learned 3M's and Amsco's ethylene oxide sterilizers cartridges are not having a CE mark. Due to this reason how does the healthcare facilities already having one of these manufacturer's machines are supplying the gas cartridges?

Tankut Gedik
Mechanical Engineer
Tel:00-90-232-2785201
Fax:00-90-232-2785284

Hitit Medical
Koruturk Mah. Uygar Sok. No:4
35330, Balcova/IZMIR
TURKEY

Dear,

As for CE-marking, it is not sufficient to say "it's CE-marked". It must state CE-marked to WHAT. There are all sorts of different CE marking eg anything electric must be CE-marked as electrically safe: this does not mean that a medical product is CE-marked for medical use, just that it is safe from an electric stand point.

It must be CE-marked to the Medical devices Directive (93/42/ECC), or other medical directive depending on device use.

The CE-mark is a declaration BY THE MANUFACTURER that the product meets appropriate provisions of relevant legislation relating to safety. Once CE-marked, the product can be freely marked anywhere in the EU without further control.

Items that do not need CE-marking include devices undergoing clinical investigation and custom made devices.

As for STERIS EO canisters: they are CE-marked. We have 3 versions: one for Domestic use, one for Canadian use and meeting EC regulations (that is CE-marked).

Both STERIS EO Steriliser and consumables are fully CE-marked to the necessary directives.

Best regards,
Christine Zeiss
STERIS limited
Healthcare Division
The Stable Block
Cornbury Park, Charlbury,
Oxfordshire, OX7 3 EH
tel: 01608 811822
fax: 01608 811854

NOTE: Chapter 1, Article 1 of the Medical Device Directive defines a "medical device". (Wim Renders)

Dear,

• Medical goods with no CE-mark can't be purchased by hospitals, except if they accept the full resposability of buying products without CE-mark. That means that if a problem happens and it is proven that it is due to the product without CE-mark, than no claim can be done to the manufacturer, but the hospital will be responsable. It is possible to import goods without CE-mark, but it is forbidden to sell them. A certification has to be done to be able to sell these goods in Europe.
• The goods manufatured by H.W. Andersen Products Inc. are allowed in the European Union because all the sterilizers have the CE-mark as well as there accessories, specially the ethylenoxide cartridges. They have all the CE certificates that allow us to sell on the European market.
• Healthcare facilities are often aware that the sterilizer has the CE-mark, but they are not neccesary aware that the ethylenoxide cartridges don't have it. It is really easy to have the CE-mark on the sterilizer, but it is much more difficult and expensive to have it on the cartridges. Andersen did the effort to have it but not its competitors. Or the healthcare facilities are buying cartridges without CE-mark but without knowing it, or they know it and they should be aware that it is their own responsability. In case of a problem they won't have any choice but taking the complete responsability. Is it worth it?

Celine VEYLAND
Andersen Products
Davy Road Gorse Lane Ind Estate
Clacton-On-Sea CO15 4XA
ENGLAND
Phone +44 1255 428 328
Fax +44 1255 222 987

I am an accredited AP as administered IHEEM employed by ST.James Hospital. To my knowledge their is no hospital within The REPUBLIC of Ireland with ISO9002 QA and the medical QA 46002 THIS GUIDANCE ON COMPLIANCE AND ACHIEVEMENT of the CE mark is complied in the guidance of EN724.
You may have to go outside your juristiction for guidance by a notified body. I recommend AMTACC for guidance in compliance or keep in touch for more specific info.

Dear,
Sterilisers in health care facilities are medical devices and must be CE-marked to the Medical Device Directive (93/42/EEC). This is not the case for sterilisers used in the industry. Ethylene oxide cartridges must not necessarily be CE-marked to the same MDD.
Kind regards,
Wim Renders