CE Certificate in Medical Devices
CE, which means Conformité Européenne (European Conformity), which is a French expression, is a document issued to circulate a product within the borders of the European Union (EU). CE studies, which first started in 1985, have become more important especially in recent years. The CE Certificate issued for many different product groups is not a quality standard and shows that the product does not harm human, animal and environmental health. The most accurate information about which product or product groups CE Certificate is issued can be found on the website of the European Commission (EC). Some CE regulations are renewed, revised or repealed for a certain period of time. You can see the most up-to-date information on this website and which companies have CE Certificates in which country.
One of the product groups with CE Certificate is medical devices. The directive valid in this field is 93/42 / EEC Medical Devices. The CE Certificate directive in Medical Devices was harmonized with a regulation issued on June 7, 2011 in our country. With the regulation published in the Official Gazette numbered 27957 by the Ministry of Health, all the necessary criteria, principles and rules for CE Certificate in Medical Devices are specified.
Purpose and Scope of CE Certificate in Medical Devices
We can summarize the purpose of the regulation with the following articles:
• Indicating the basic criteria that any medical device or accessory within the scope of the regulation should have.
• To prevent dangers that may arise from the use of this device and accessories.
• Establishing the necessary rules to ensure the health and safety of people who manufacture, sell, carry or use the devices.
• The CE Certificate in Medical Devices also specifies the procedures and principles for the control of the design, classification, production, placing on the market and use of these devices.
Products covered by the CE Certificate in Medical Devices
The 93/42 / EEC Medical Devices Directive covers many products. Detailed information about these products can be obtained from the original regulation text or the regulation text published in the Official Gazette in our country. Among the products that CE Certificate is issued in Medical Devices are the following:
• Anesthesia and intensive care services,
• In emergency departments,
• In orthopedics and rehabilitation applications,
• In cleaning and disinfection processes,
• In wound care and treatments; in dressing applications,
• In dental treatments,
• Cardiovascular implants
The medical devices and accessories used are within the scope of the regulation.
Although the scope of CE Certificate in Medical Devices is very wide, it is worth noting that not every product is covered by the certificate. Some products that are not covered are:
Devices placed directly in the human body
• Devices used for cosmetic purposes
• Products, equipment and accessories used in in vitro medical diagnostic procedures
• Products produced from human cells, tissues and transplant organs
• Many products that fall under the category of personal protection devices
Product Classes in Medical Devices with CE Certificate
There are three different product groups within the scope of the regulation:
• Class 1: Products with low risk group
• Class 2: Products with moderate risk levels
• Class 3: High risk products
All of the products in Class 2 and Class 3 require the approval of an accredited certification body for the CE Certificate. Accredited institutions should also approve CE Certificate for some of the products in the low risk product group. For example, for products supplied as sterile or used for measurement purposes and specified as Class 1s and Class 1m in the regulation, an application must be made to the accredited certification bodies when it is required to obtain a CE Certificate in Medical Devices.
How to Get CE Certificate in Medical Devices?
The CE Certification procedures for medical devices are also largely the same as other CE product groups. Businesses that are active in this field and want to obtain a CE Certificate are recommended to receive a few basic trainings. Support from a consultancy firm must be obtained in order for the process to proceed quickly and smoothly. The consultancy firm that works together helps businesses about the tests to be done about the product, the documents to be edited and, most importantly, the documents that should be in the technical file. In this context, it is worth noting that in the technical file, which is one of the most important parts of the CE Certificate in Medical Devices, the following information must be present:
• Product introduction: The content of the product, its intended use, under what conditions it should be used, if any, side effects etc.
• Product class information
• Basic requirements: Standards, test reports, product user manual etc.
• Risk analysis
• Clinical evaluation
• Product verification information
Accredited certification bodies review this technical file and visit companies to audit their business sites. If a mistake / deficiency related to the processes concerning the product is detected, it is requested to create a regulatory / preventive action for them. After these steps are completed, CE certificate is given to the products of the applicant company.
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