Medizinprodukte

Medical Devices

are instruments, apparatuses, devices, software, implants, reagents or other items intended, among other things, for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases in human beings.

MDD

Directive 93/42/EEC

In Germany, the Medical Devices Act (Medizinproduktegesetz – MPG) of August 2, 1994, regulates the marketing of medical devices. It serves for national implementation of three European (parent) directives (90/385/EEC [active implantable medical devices], 93/42/EEC [other medical devices], and 98/79/EC [in vitro diagnostics]), which have been supplemented or amended, respectively, by subsequent amending directives, most recently by Directive 2007/47/EC of September 5, 2007, effective March 21, 2010. The MPG and its implementing statutory ordinances moreover comprise further national regulations that mainly serve to monitor medical devices that are on the market (market surveillance or “vigilance”).

1. § 3 of the MPG contains the legal definition(s) of the term medical device under the Directive in №s 1 to 4.
2. The following classification makes no claim to be complete.
3. Annex IX to Directive 93/42/EEC contains the legal classification for medical devices under this Directive in the EU

MDR

Regulation (EU) 2017/745

The Medical Device Regulation (EU) 2017/745 (MDR) entered into force on May 25, 2017. The MDR replaces the previous Medical Device Directives 93/42/EEC on medical devices (MDD) and 90/385/EEC on active implantable medical devices (AIMD). The MDR applies directly in the member states of the European Union and therefore does not need to be transposed into national law.

Nevertheless, national specifications are required that regulate, for example, which authorities are responsible in the respective country, and which languages are mandatory for instructions for use and declarations of conformity.

These specifications are made by the Medical Devices Implementation Act, MPDG (Medizinprodukte-Durchführungsgesetz), and (future) national regulations.

1. Article 2 of the MDR contains the legal definition(s) of the term medical device.
2. Annex VIII to Regulation (EU) 2017/745 contains the legal classification for medical devices under the MDR in the EU.

 

Classification

Based on the applicable statutory requirements for medical devices, the manufacturers assign each of these to a specific class. Here, based on Directive 93/42/EEC Annex IX to the Medical Device Directive (MDD) or the Regulation (EU) 2017/745 Annex VIII, respectively, a distinction is made between four classes that, as risk classes, also imply different requirements for market access. The criteria of duration and invasiveness of the application, site of the application, and the feature active/not active play a role in this risk classification.

MediProdukt Kl. 1

MediDevice Kl. I

low risk

Generally all non-invasive products and products used invasively for a short time under certain conditions, low risk potential, such as mixing cannulas.

MediProdukt Kl. 2a

MediDevice
Kl. IIa

moderate risk

Generally products used invasively for a short time and products used invasively for a longer time under certain conditions, moderate risk potential, such as prosthesis lining material, fissure sealants, dental prostheses

MediProdukt Kl. 2b

MediDevice Kl. IIb

high risk  

Generally all implantable products and products with increased methodical risk potential, such as disinfectants

MediProdukt Kl. 3

MediDevice
Kl. III

very high risk

Products with very high risk potential, e.g. for application on the heart, central nervous system, or circulation system, development of a biological effect

 
VDDI
mdc Zertifiziert
DIN Normen Ausschuss
DIN Normen Ausschuss
 

Regulatory Affairs regulatory.affairs@detax.de 
Phone +49 7243 - 510-268
Fax +49 7243 - 510-222

DETAX MediGuide
medi.guide@detax.de
Phone +49 7243 - 510-226
Fax +49 7243 - 510-222

Person Responsible for Regulatory Compliance QP.medical.devices@detax.de
Phone +49 7243 - 510-268
Fax +49 7243 - 510-222

 
 
MediGuide

DETAX MEDIGUIDE

Wir unterstützen unsere Kunden bei Fragen rund um das Thema Medizinprodukte

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Zertifizierung

ZERTIFIZIERUNG

Zertifiziert nach den neuesten Normen, Richtlinien und Verordnungen für Medizinprodukte

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MDR Ready? FAQ

MDR FAQ

 
 
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Welcome at DETAX online – Your specialists for medical material.

For more than 65 years, we have been developing silicones and light-curing resins for dental and other medical applications. The polymer chemistry of materials is our universe.

DETAX GmbH & Co. KG
Carl-Zeiss-Str. 4
76275 Ettlingen
Germany

Phone +49 7243 / 510-0
Fax +49 7243 / 510-100 
post@detax.de

 


BRAND PRODUCTS DENTAL: blue eco • blue eco scan® • Cavidex®   • Detaferm® • Detaseal® Adhesive rapid • Detaseal® antilock • Detaseal® bite • Detaseal® function • Detaseal® hydroflow • Detaseal® hydroflow heavy • Detaseal® hydroflow lite • Detaseal® hydroflow mono • Detaseal® hydroflow putty • Detaseal® hydroflow Xlite • Detaseal® soft2putty • Drala® • Drala® Phosphate Cement • easyform • exaplast • Fermin • Flexistone® • Gingivamoll® • glassbite • good morning spray • greenbite apple • greenbite colour • hydro C • Implant Mask • implantlink semi® • implantlink® semi Classic • implantlink® semi Forte • implantlink® semi Xray • Lustrol® • milkbite • Molloplast® B • mollosil® • mollosil® plus • monoprint supra • onetime perfect • Permaliner • pixelbite • silaplast • silaplast Futur • silasoft® • silasoft® direct • silasoft® Normal • silasoft® Special • sili Adhesive • silone® • smartfluorid® • smartfluorid® laquer • smartprotect® • smartprotect® soft· smartseal® cervi • smartrepair® • smartrepair® rosa • smartrepair® system • smartseal® & loc / F • smartseal® etch • sta-seal • sta-seal f • tempofill® • tempofill® 2 • tempofit® • tempofit® duomix • tempofit® finish • tempofit® premium 10:1 • tempofit® regular 1:1 • tempofit® semi 10:1 • tempolink® clear • tempolink® single • trayloc A

BRAND PRODUCTS AUDIO: acrylon® • acrylon® automix • addition futur • addition junior • addition mini • addition mini junior • addition protect • addition rapid • addition spectra • addition supra® • addition ultra® • aqua coat • aquaplus colormix • aquaplus® • bioflex • bioplast • cat futur • classic futur • detax addition • detax flextime® • dip coat • direct mold • duglasil® • duglasil® express • durosil® • durosil® • earflex® clear • earflex® rainbow • earflex® rose • express coat • frosty coat • green eco • microporlack • pink mix • pink putty • preclean • protect mold • smartcare® • smartclean® • smartclean® foam • smartclean® pen • smartclean® tabs • softwear coat • softwear® 2.0 • super coat

BRAND PRODUCTS 3D: Cast Separator 2.0 • Cast Seperator PU • Cast Seperator PU • freeprint® c&b • freeprint® cast • freeprint® cast • Freeprint® cast 2.0 • FREEPRINT® denture • FREEPRINT® gingival • FREEPRINT® IBT • freeprint® model • FREEPRINT® model • FREEPRINT® model 2.0 • FREEPRINT® model T • freeprint® mould • Freeprint® mould • freeprint® ortho • freeprint® shell • freeprint® splint • FREEPRINT® splint 2.0 • FREEPRINT® temp • FREEPRINT® tray • luxaprint® cast • luxaprint® cast 2.0 • luxaprint® flex • luxaprint® mould • luxaprint® shell • luxaprint® cocoon • luxaprint® flex coat • luxaprint® shellac • luxaprint® shellac color • luxaprint® shellac skin tones • medicalprint® mould • medicalprint® shell

Detax. As a brand, this name stands for high-quality medical devices. Since 1954, we have been developing silicones and light-curing resins for dental and other medical applications. The polymer chemistry of materials is our universe. Our enthusiasm and innovative strength is ingrained in every one of the products that you will become familiar on this Website.

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We develop hydrophilic impression making silicones for every indication (corrective and double mix technology, kneadable working impression making for functioning rim design, sandwich technology, monophase impression making). Precision impression making materials of lightly flowing consistency with ideal flow characteristics, maximum wetting power, and elastic resilience. Regular set, fast set or super fast set with thermoactive setting characteristics and a defined snap set, kneadable putty, color violet with wildberry flavor. Ear impression making silicones in 50 ml double cartridges specially for IO/CIC changes with lightly flowing starting consistency, even for narrow auditory canals or patients with chronic pain. Ear impression making silicones for children and young people (paediatrics), pressure-less impression, no ingress of soft tissue. Ear impression making material for hearing-protection adjustments, low squeezing pressure, stable, does not run out of the ear, short time in the ear, skin friendly, non adhesive. Highly elastic resilience, easy to remove, 35 Shore A monophase impression making silicone in medium tray consistency. Harmonized consistencies of tray and corrective material. Transfer silicones, quick-setting and clearly transparent A-silicone base bite registration material, medium flow, thixotropic, to be applied directly on the row of teeth, no flowing away into interdental chambers, X-ray transparent matrix material, crystal clear, final hardness 80 Shore A, for light hardening of composites. Scannable VPS bite registration material for the powder-free 3D data acquisition for all CAD/CAM/CIM processes (stripe light projection, laser triangulation and CEREC), 32 Shore D, short time spent in the mouth. Permanently plasticizing relining silicones, direct relining in the dental practice chairside or for processing in the dental laboratory. Broad indication spectrum (obturators and mouth guards) with plaque inhibitors, clinically tested and scientifically documented. Secure bond to prosthetic acrylate. Additional crosslinking duplicating silicones and laboratory plasticines 85 Shore A for precasts, control bites, fixing of artificial teeth, models for prosthetic repairs. Permanently elastic otoplastic silicone, buoyant, direct fitting of water plugs and ear canal plastics, for the indirect manufacture of soft HdO and protective plastics, for PNP, 3D cast technology, permanently keeps its color. Even with extended processing time for series manufacture in the obtoplastics laboratory. Air-drying silicone paint for water plug plastics antibacterial with silver particles. Bis-acrylic composite 10.1 for temporary crowns, bridges and long-term temporaries with elastic phase and maximum and flexural and abrasion resistances, low polymerization temperature, translucent colors: A1, A2, A3, A3,5. Composite-based fissure sealant with wet bonding technology. Protective lacquer for exposed root dentine with high degree of cross-linking based on multifunctional (meth)acrylate has a desensitizing effect, forms a barrier against erosion, thereby reducing cervical sensitivity. Transparent fluoride varnish with amino-fluoride, mouth wash. Flexible gum masks for dental master and saw models, dimensionally stable, for a naturally aesthetic gingival look in tubes or cartridges. Dental cements for definitive and semi-permanent implantation, fasteners, long-term temporary fixing cements, plastic-based radio-opaque, cementation of supra-constructions, dual hardener system. Ready-to-use modeling resin, as a gel or paste, MMA-free, combustible without resins, no polymerization shrinkage. Gum epithesis material, hot curing. Kneable UV plastics for manufacturing biocompatible splints & templates. Plastics for 3D print systems: dentistry models, casting objects, IIa-class clear transparent resins for biocompatible implant templates and splints, KFO (DIN) base parts, long-term temporary K&B composite and supplies in total prosthodontics

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