Compliant with legal requirements such as 9342ewg or fda 21 cfr part 11, thereby safeguarding our customers. With thousands of personal care and consumer products on the market, it can be overwhelming to know which ones are safer and healthier for your family. Download area download information on the full range of our products quickly and easily as pdf files. The essential requirements of the medical device directive 93 42 eec referred to as the mdd set out the detailed requirements for labelling of medical devices in annex 1 paragraphs 8. The content of this page deals only with the medical devices directive 9342eec. Md 1111 software md 1106 active dental devices md 1108 active rehabilitation devices and active creation date. You can choose from the wide range of kavos top class dental turbines. The imagis system is evaluated as medical device according to class i, guideline 9342ewg. It is ce marked according to article 17, which requires that the product has undergone a conformity evaluation according to article 11. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. They must be kept close to the unit and in readiness whenever required.
Page 42 8 miscellaneous mmoll blood sample or control solution quantity ht lt appears. Essential requirements annex i, 9342eec as compliance. Medizinprodukterichtlinie 9342ewg medical device directive mdd. Reporting changes to your notified body vicky medley head of qms, medical devices. P1801426144693 stuttgart 20190405 head of certification body. The support arm can be adjusted both horizontally and vertically and remains balanced in any position. This checklist has to be filled out for each device.
B council directive 9342eec of 14 june 1993 concerning. The amendments are being done either by including those into other directives, for example in the invitrodiagnostic medical device directive, or by means of a separate document which covers a specific aspect, for example, the directive 200070ec of the european parliament and the council of november 16, 2000, amending council directive 93 42. Reliable processes and secure backups due to the creation of locally and globally comprehensive parameters, reports, and dialog boxes. Council directive 93 42 eec of 14 june 1993 concerning medical devices official journal l 169, 12071993 p. This text shows a way how to cope the mass of information and referring between the three standards iso 14971, en 62366 and 606011, 3rd edition with using a special software for risk management documentation. They areconsidered the state of the art, and are considered not mandatory but in reality you will be unable to cemark a device without the use of harmonized eu standards. Qualification and classification of stand alone software. Eu medical device directive 9342eec labelling requirements. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. Manufacturers of medical devices need to fulfill the requirements of the medical device directory 9342ewg.
Risk management documentation, iso 14971, iec 606011. This document is then part of the documentation which has to be sub. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Any active medical device, whether used alone or in combination with.
The surveillance will be held as specified in annex ii, section 5. Medisana meditouch 2 instruction manual pdf download. In general of the guidance on software given in this recommendation. Council directive 9342eec of 14 june 1993 concerning medical. Council directive 93 42 eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Valid from 20190405 valid until 20240323 registration no. Brochures steam sterilizers catalogue as 6918 brochure asl series brochure. Directive 93 42 eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu.
Softwarebased risk management documentation for medical. Mdd richtlinie 9342ewg medizinprodukterichtlinie deutsch. Medical product regulation states that medical products can be freely handled on the european market as long as they fulfill basic requirements. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to. Download qualification and classification of stand alone software. Council directives 90385eec and 9342eec, will consolidate two existing legal provisions and replace both the current medical device directive 9342eec and the active implantable medical device directive 90385eec. Council directive 93 42 eec of 14 june 1993 concerning medical devices.
The content of this page deals only with the medical devices directive 93 42 eec. References see page with references for each device. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. The manufacturer confirms conformity of a medical product with basic requirements by labeling every single product with the ce mark. Medical device directive 9342eec cemarking qnet, llc. Overview a medical device is defined in directive 93 42 eec as. For dental drill guides the material is classified and certified as a medical device class i, following the european regulation 9342ewg. Our quality has been confirmed by our extensive certifications from the very beginning. Wiam supports companies in finding information, managing data, linking knowledge. Council directive 9342eec of 14 june 1993 concerning medical devices.
Directive 200070ec of the european parliament and of the council of 16 november 2000. When the company was established in 1994, all tq systems were certified in accordance with din en iso 9001. These sections are reproduced below for your information or. Overview a medical device is defined in directive 9342eec as. As low as reasonable possible selection from basiswissen medizinische software, 2nd edition book. Precise observance of these instructions is a precondition for use. For over 100 years, our employees have been developing, manufacturing and selling highquality products that set new market standards. Each kavo dental turbine is the result of extensive ergonomic and anatomical studies with consistent dimensions, angles and contours for balanced handling. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. European medical device directive essential requirements.
Because of the many types of devices covered by the mdd, the specific requirements depend on the. Operating instructions speedy easyrunning, rigidframe wheelchair subject to ec directive 9342ewg for medical devices printed in germany 072010. The amendments are being done either by including those into other directives, for example in the invitrodiagnostic medical device directive, or by means of a separate document which covers a specific aspect, for example, the directive 200070ec of the european parliament and the council of november 16, 2000, amending council directive 9342. Kavo has made a significant contribution to the history of dentistry with its consistent innovations. In the process for the system evaluation acc 9342eec annex ii without clause 4, annex v and annex vi as well as for ec typeexamination acc. Directive 9342eec, then the software shall be qualified as a medical device.