93/42 / EEC-MEDICAL EQUIPMENT
A 2014/33 / EU elevator decree has been issued to ensure that elevators are put on the market in such a way as not to pose a health and safety risk to end users. This rule applies to elevators and elevator safety elements used in buildings.
WHAT SERVICES DO WE OFFER FOR MEDICAL PRODUCTS?
SZUTEST provides the following medical services:
- 93/42 / EEC CE Marking Certification
- EN 60601-1 Testing
- Measurements in clean rooms
- Biomechanical tests - Implant tests
- ISO 13485 certification
WHICH PRODUCTS ARE MEDICAL PRODUCTS?
In accordance with the applicable directive; "Medical Device" means any instrument, apparatus, device, software, material, or other product, regardless of whether it is used alone or in combination, along with any accessories, including software designed by its manufacturer for use specifically in diagnostic and / or therapeutic purposes, and is necessary for its proper use, intended by the manufacturer for use by people for the purposes of:
- diagnosis, prevention, monitoring, treatment or alleviation of the disease,
- diagnosis, monitoring, treatment, relief or compensation for injury or disability,
- research, replacement or change of anatomy or physiological process,
- control of conception, and which does not reach its main intended impact on the human body or with its help by pharmacological, immunological or metabolic means, but which can be helped by its functions by such means.
WHAT ARE THE PRODUCT CLASSIFICATION TYPES?
Classification references in Appendix IX to MDD:
- Low-risk class I devices, such as external patient support devices. Class I devices that are supplied sterile are considered class Is devices, and class I devices with a measurement function belong to the class Im.
- Class IIb, medium-risk class IIb devices, such as electro-medical devices and implants
- High risk class III devices, such as cardiovascular catheters.
FOR WHAT CLASSES OF PRODUCTS IS CERTIFICATION REQUIRED?
All Is, Im, IIa, IIb and Class III devices require the approval of an authorized body, such as SZUTEST No. 2159 and a CE medical certificate. Manufacturers of these products should contact the authorized body. As an authorized CE certification body, SZUTEST can issue CE certificates for specific devices. After obtaining a CE certificate for your medical device, your data will be registered in EUDAMED (EU Databank), and you will receive the right to freely move your products to the European market.
WHAT IS A TECHNICAL FILE? WHAT SHOULD BE INCLUDED IN THIS?
The content of the technical file included in the technical files of medical equipment should be as follows:
Product Description: Appointment, method of use, list of components, content, duration of use, patient population, indications / contraindications, side effects and other descriptive information.
Classification: The medical device manufacturer must indicate the class of device and provide a justification (class I, class Is, class Im, class IIa, class IIb or class III) based on the requirements of Annex IX 93/42 / EEC.
Basic requirements of the Cheklist: The manufacturer must explain in detail using the checklist that the medical device complies with the basic requirements given in Appendix I and how the performance of the medical device is demonstrated. In this explanation, the relevant harmonized standards, test reports, relevant parts of the technical file and documents in the quality management system should be indicated as references.
Risk management: the manufacturer must perform a risk analysis of the design, production and after-sales service of the product.
Clinical assessment: Clinical assessment should be carried out in accordance with the Meddev 2.7.1 guidance document and in accordance with the requirements of the Annex X of Medical Devices Directive 93/42 / EEC. Clinical data should include data from the same or similar devices, and the clinical literature on these devices should be systematically evaluated by an experienced specialist with relevant scientific knowledge.
Validation. All parameters that may affect the safety and performance of the medical device, and the processes that may affect these parameters should be checked. Records of this confirmation should be included in the technical documentation.
IS THE IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM FOR THE MANUFACTURERS OF THE MEDICAL PRODUCT?
In accordance with the current directive, many authorized bodies are appointed for applications covering quality management system evaluations. The requirements for a quality management system to which manufacturers of medical devices must comply are defined in the relevant annexes to the directive.
The implemented Quality System must ensure that the products comply with the requirements of the medical equipment directive. All elements and requirements adapted to the quality management system should be systematically documented in the form of written principles and procedures (quality program, quality plan, quality manual and quality records).
Our partners are SZUTEST, accredited by TURKAK (Turkish Accreditation Agency) and IAS for medical devices in accordance with ISO 17021. Our accreditation area covers EN ISO 13485: 2012 and the assessment of the quality management system implemented by manufacturers based on this standard.