Vastuskiri

Dear Hasmik Kirakosyan,

Thank you for the inquiry.

The manufacturer follows the MDR and the use of standards is voluntary.

All relevant requirements in Estonia concerning medical devices can be found in the national Medical Devices Act.

As the titile suggests, for requirements applicable to Bulgaria, please contact the competent authority in Bulgaria.

Please do not hesitate to contact us for further information or with any questions.

Best regards,

Egle Audova

Chief Specialist

Department of Medical Devices

Phone +372 5566 7596

[email protected] | [email protected]  

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Dear Sir/Madam,

MDSS acts as Authorised Representative according to MDR 2017/745 for several non-EU manufacturers worldwide. Several of them plan to produce reusable medical devices, which are intended to be processed for reuse. MDR Annex I section 23.4. (n) requires the following information:

(The instructions for use shall contain all of the following particulars:) if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilization appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses;

EN ISO 17644-1 (“Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices”) also requires in chapter 6.1.4 to consider available national and international standards and directives.

Besides chapter 6.1.4, the manufacturers fully comply with EN ISO 17644-1. However, MDSS on behalf of several manufacturers would like to ask, if any national standards or directives other than EN ISO 17644-1 are applicable to reusable devices which are to be placed on your local market and are intended to be processed for reuse.

If applicable, please confirm, that there are no additional requirements specific to your territory.

Thank you and Best regards,

Hasmik Kirakosyan (she/her/hers)

Registration Department

MDSS GmbH

Schiffgraben 41, 30175 Hannover, Germany

Tel.: +49 511 6262 8630

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MDSS GmbH ● President: Ludger Möller ● Trade Register: Hannover HRB 57318 ● VAT ID: DE 177346163

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