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Information about the EU Medical Device Regulation

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Our medical devices comply with the EU Medical Device Regulation 2017/745 (MDR).
The rules and standards of the MDR regulate production, distribution and activities after placing medical devices on the market in Europe. These measures were introduced to improve the safety, quality, reliability and performance of medical devices.

Further information is available from Eurocom, BIV-OT or DGIHV.

Legend: Identification of Streifeneder medical devices

Medical device
CE marking
Manufacturer
Distribution
Article number
Date of manufacture
Lot number
Note the instructions for use!
Note the loading weight
For multiple use on 1 patient
Contains latex
Store in a dry place
Protect from sunlight
Disposal: residual waste
Disposal: not residual waste
Serial number

Glossary

Medical device

“Medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; providing information by means of in vitro examination of specimens derived from the human body, including from organ, blood and tissue donations; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but whose mode of action may be supported by such means. The following products shall also be deemed to be medical devices:
products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Accessory for a medical device

“Accessory for a medical device” means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).

CE marking of conformity

“CE marking of conformity” or “CE marking” means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this regulation and other applicable Union legislation on affixing the respective label;

Custom-made device

“Custom-made device” means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications that specifies, under that person’s responsibility, the precise design and characteristics of the device, and is intended for only one patient to exclusively to meet their individual condition and needs.

System

“System” means a combination of products, either packaged together or not, which are intended to be connected or combined to achieve a specific medical purpose.

Procedure pack

“Procedure pack” means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

Making available on the market

“Making available on the market” means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

Placing on the market

“Placing on the market” means the first making available of a device, other than an investigational device, on the Union market.

Putting into service

“Putting into service” means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended use.

Intended use

“Intended use” means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.

Rollen

Authorised representative

“Authorised representative” means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.

Distributor

“Distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.

Health institution

“Health institution” means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health.

Importer

“Importer” means any natural or legal person established within the Union that places a device from a third country on the Union market. 5

Manufacturer

“Manufacturer” means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

Notified body

“Notified body” means a conformity assessment body designated in accordance with this Regulation.

Person responsible

The supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them should be carried out within the manufacturer’s organisation by a person responsible for regulatory compliance, who fulfils the minimum conditions of qualification for the role.

Economic operator

“Economic operator” means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3).

Frequently asked questions

How do I identify a medical device?

Check the packaging to identify a medical device from Streifeneder ortho.production GmbH. If it bears the marking MD for “Medical Device” and the CE marking, it is a medical device. You will also find this information in the instructions for use.

If the product has a CE marking, was an EU declaration of conformity issued?

All medical devices from Streifeneder ortho.production GmbH bear the CE marking. You will find the marking on the packaging, in the instructions for use and also on the product.

What is the risk class for the medical device?

All medical devices from Streifeneder ortho.production GmbH are class 1 products.

Do special storage and transportation conditions have to be observed for the product?

Please see the instructions for use for this information. Generally, the products should be stored in a dry place and protected from sunlight (symbols on the label).

Does the product have an expiration date?

Please see the label to determine whether the product has an expiration date. Information on the useful life of medical devices is provided in the instructions for use.

Can you provide us with the instructions for use for the product?

Instructions for use are included with most medical devices. Some medical devices come only with a package insert with basic information.

Are instructions for use not required in some cases?

Some products from Streifeneder ortho.production GmbH do not require instructions for use. The products can be used safely without instructions for use.

Does the product required a LOT or serial number?

Every medical device from Streifeneder ortho.production GmbH is marked with a LOT or serial number and identified with the symbols [SN] / [LOT]. You will find this on the packaging and/or the product.

Are materials also medical devices?

Materials as such are not medical devices within the meaning of Regulation (EU) 2017/745; they are deemed raw or other materials for the fabrication, by a qualified person, of a custom-made device as defined by Regulation (EU) 2017/745. The required tests were of course taken into account for materials with skin contact according to the Streifeneder processing recommendations.