DETAX MediGuide

DETAX MediGuide

 
 

We support our customers on matters in all aspects of medical devices and advise them on the necessary registrations DETAX brands to access the market, OEM or custom-made materials. Our specialists have many years of experience in interpreting and implementing regulatory requirements. You will recognize DETAX medical devices from the blue logo. All medical devices are labeled with the respective class. We provide you with the necessary documentation, such as ISO certificate, declaration of conformity, product labels, safety data sheets and technical data sheets.

We are happy to advise you on all questions about medical devices.

DETAX MediGuide
custom.made@detax.de
Phone +49 7243 - 510-226
Fax +49 7243 - 510-222

MDR Ready?

According to Article 120 MDR, the transition period ends on 25.05.2020!  All medical devices have to comply with the new regulations.

Need further assistance? Contact us at medi.guide@detax.de

FAQ

What is the Medical Device Regulation (MDR)

The Medical Device Regulation (MDR 2017/745) replaces the current EU Directives on Medical Devices (93/42 / EEC) and Active Implantable Medical Devices (90/385 / EEC).

When does the MDR come into force?

The MDR came into force on May 25th 2017.

When do manufacturers of medical devices have to apply the new MDR

The transition periods are described in Article 120 of the MDR. Accordingly, the date of application of the MDR is May 26th 2020. At the latest and after that, manufacturers must submit an MDR certificate when they first place a product on the market. For all new devices and all previous class I devices, the MDR is mandatory from this date on.

Will not expired CE markings continue to be valid after the introduction of the Medical Device Regulation?

Yes. All CE certificates will continue to be valid until expired or up to five years after application. However, they lose their validity by May 27th 2024 at the latest.

This means that there is a transition period for medical devices of Class II, which have been certified under the Medical Device Directive, maximally until May 26th 2024. Note: The transitional period always depends on the duration of the manufacturer‘s CE certificate.

Also important is the so-called „sales regulation“ of compliant devices according to MDR article 120 paragraph 4: The last day for the provision of medical devices is therefore May 27th 2025.

Under what conditions may MDD-certified devices (class II medical devices) continue to be placed on the market after the date of application of the MDR?

If the devices still meet the requirements of the MDD

There must be no significant changes in the design and purpose of the products

However, the requirements of MDR for post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices are valid instead of the corresponding requirements of EU Directive 93/42/EEC

What are the most important MDR changes for medical device manufacturers?

Some of the most important changes are:

Higher classification of medical devices by risk, duration of contact and invasiveness. MDR encourages medical device manufacturers to review the new classification rules and to update their technical documentation accordingly

Substantially expanded general safety and performance requirements (previously general requirements)

Additional documentation requirements such as Post Market Surveillance Plan / Report (PMS), Post Market Clinical Follow Up (PMCF), Periodic Safety Update Report (PSUR)

Medical device manufacturers must designate a qualified person in the company who must have qualified medical device expertise

Introduction of UDI labeling to improve the traceability of medical devices

New regulation of market surveillance with shorter reporting deadlines

Grandfathering is not intended: All currently certified medical devices must be re-certified to meet the new requirements

What are the most important MDR changes for distributors?

General obligations of distributors are described in Article 14 of the MDR. Using a sampling method which is representative of the devices supplied, the distributor should check whether the device has been CE marked and that the EU declaration of conformity of the device has been drawn up. Furthermore, the distributor should check that the device is accompanied by the information to be supplied by the manufacturer and, where applicable, an UDI has been assigned. In addition, Article 14 describes further obligations for handling non-compliant devices, reporting obligations to manufacturers and authorities, and documentation requirements for complaint management.

What changes do occur in reference to notified bodies?

All notified bodies must be re-accredited by the local authorities under the new MDR for their tasks. It is expected that a significant number of notified bodies may not be renamed again or to the same scope, which might force some medical device manufacturers to change their notified bodies.

What does the new regulation mean for private labels?

The previous PLM / OEM constellations are no longer accepted by the Notified Bodies. Following legally compliant concepts arise for the future cooperation:

DETAX Standard products:
The manufacturer provides you with its original product. Then, you are the distributor of our standard product.

Co-branding („Made by“ variant):
You act as a distributor, importer or re-packer of products and distribute the products with your design. The name of the manufacturer of the products can also be seen on the label.

New OEM / PLM procedure:
As before, you act as manufacturer meaning you are responsible for the complete registration process of the products. In this variant, the name of the manufacturer is not on the label. NEW: The prerequisite for this practice is the complete disclosure of the technical documentation by the manufacturer (unlikely in practice).

Regardless of the concept presented above, there is a Quality Assurance Agreement (QAA) between you and the manufacturer is needed for further cooperation, which regulates e.g. the duties of the distributor and the traceability of the products.

March 2019

Knowledge to the customer: for more transparency in the “jungle” of different risk classes for medical products, we created a corporate logo to distinguish DETAX medical devices of class I, IIa and IIb.  You will easily find these recognizable emblems “I am a Medical Device” in our product catalogues.

MediGuide
 
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CERTIFICATION

CERTIFICATION

Certified according to the latest standards and directives on medical devices.

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MDR Ready? FAQ

MDR FAQs

DETAX Logo
DETAX Logo
 

Welcome at DETAX online – Your specialists for medical material.

For over 60 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

 


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Detax. As a brand, this name stands for high-quality medical devices. For over 60 years, 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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