CE CERTIFICATE IN MEDICAL DEVICES
Medical Devices CE Certificate Regulation is one of the most important elements that ensure the conformity of medical devices to the necessary conditions and appropriate production, market and use in a way that does not pose a threat to people´s health and safety. In this context, any medical device that does not have a CE certificate / certificate cannot be placed on the market. The bases on this subject; It can be specified as the 93/42 / EEC Medical Device Directive and the 93/42 / EC Medical Device Directive.
Medical device controls are required. In terms of high-precision medical devices that directly affect human life and usually require significant investment, this situation represents a greater necessity. Medical devices at many levels have substantial maintenance costs, and some are relatively short-lived. European Regulations on Medical Devices focus on the responsibilities of the producers of products. CE marking cannot be performed without technical documentation that includes risk analysis and references to the essential requirements of the regulations, as well as the declarations of conformity published by the manufacturers in accordance with the relevant regulation.
According to the Medical Device Regulation; The controls and tests to be applied must be determined according to the risk level of the medical device. Necessary tests and controls are applied to high risk level products within the scope of this regulation.
Risk classes of medical devices are indicated as follows;
* Class I - Low Risk,
* Class IIa - Medium Risk,
* Class IIb - Medium Risk,
* Class III - High Risk.
Medical Devices Products Under CE Certificate
»Operating Room Devices
»Professional Medical Devices
»Analysis Test Equipment
»Aspirator Devices
»Physical Therapy Devices
»Patient Room Devices
»Medical Compressor
»Pendant
»Respiratory Devices
»Therapy Devices
»Diagnostic And Diagnostic Devices
»Newborn Units and Devices
»Intensive Care Devices
High Speed ??Surgical Motor Systems
»Legend Gold Touch
»Attachments
»Legend Gold
»Straight Attachments
»Legend Platinum
Spinal Shaver Device
»Nucleus Extraction Blades
»Midas Rex Spine Shaver SC1 Handpiece
Ultrasonic Aspirator / Dissector Devices
»Sonoca 300
" Hand tools
»Sonoca 400
Ultrasonic Liposution Device
»Liposuction Hand Tools
»Sonoca Lipo
Harmonic Scalpel Cutting and Coagulation Device
»Sonoca 190
»Harmonic Scalpel Hand Tools
»Harmonic Scalpel Handpiece 98-K190 and 98-K325 (New Product)
Cold Plasma Coagulator
»CPC-3000
»CPC-1500
»CPC-1000
»Accessories
Argon Cautery Device
»Arco-1000
»Arco-2000
»Arco-3000
»Accessories
Transcranial Doppler
»Four-Lite
»Smart-Lite
»Digi-Lite
»Intra-View
»Four-Vi
Radiosurgery (Micromar)
»Cranial radiosurgery system
»Aimrad - radiosurgery planning software
»Fractional stereotactic radiotherapy system
»Body frame radiosurgery and radiotherapy system
Retractor System
»Speed-Tract
»Vascular and General Surgery
»Integra Omni Track Fast System Wishbone Retractor (urology)
»Integra Omni Track Fast System Wishbone
In order to indicate or demonstrate that the manufactured medical devices meet the essential requirements, these devices must pass some conformity assessment methods / tests. These methods / tests differ according to risk classes. Medical devices whose conformity is tested and passed these tests are given CE Certificate. And CE mark is attached to the products. The responsibility for placing the CE mark on the product belongs to the manufacturer. CE mark can be attached to the product or its packaging. The important thing here is that this sign is visible. In our country, there are private companies that work on giving CE certificate / certificate to medical devices. Producers can obtain CE Certificate for the products they produce by contacting these private companies.
CE Certificate Process for Medical Devices
Medical Devices are subject to CE certificate regulations in accordance with European regulations. In other words, a product that is defined as a medical device or medical device must carry a CE mark and obtain a CE Certificate.
AT Type: T.C. These are the rules established by the Ministry of Science, Industry and Technology, published or accepted with the principle of creating our industry and realizing a common standard production in the world.
EC Type Examination: It covers the verification and certification of the medical devices to be produced by the approved institution whether they meet the requirements of the legislation.
EC Verification: It is the process in which the manufacturer makes a statement by confirming that the products are conforming to the EC type evaluation and that they meet the provisions of the legislation.
EC Type Conformity Certificate: The manufacturer declares that the medical devices meet the legislative conditions to be applied to them with the samples defined in the EC type examination certificate, and the manufacturer establishes a written declaration of conformity after adding the CE mark and introductory letters to all medical devices. After these stages, all products bearing the Ce mark can be placed on the market.
CE conformity mark: The determination of EC conformity can be affixed on the medical devices of the manufacturer, as a distinctive mark, in a visible, indelible and easily readable manner.
"As EKOL Certification Body, you can contact us to benefit from our CE Certificate service for Medical Devices and get detailed information."