CE MARK ON MEDICAL DEVICES AND 2017/745 MDR- 2017/746 IVDR
The CE signis an official certificate mark known internationally as the European Economic Area, which has a Turkish equivalent of the European Economic Area and indicates whether the products sold here have standard compliance with various factors such as health, safety, and the environment. CE, which means Conformité Européenne (European Conformity), a French phrase, is a document for ensuring the circulation of a product within the European Union (EU). The CE Certificate issued for many different product groups does not have a quality standard and shows that the relevant product does not harm human, animal and environmental health.
In order to sell some products in the countries within the European Union, it is obligatory for the product to bear the CE marking. Therefore, CE certificate is needed to sell in the European market safely and in accordance with the law. Otherwise, products that do not have this mark cannot be sold.
What is a Medical Device?
The medical device is "on humans, including the equipment necessary for the application intended by the manufacturer; diagnosis, prevention, monitoring, treatment or mitigation of the disease, diagnosis or compensation of any injury or disability, examination, modification of anatomy or physiological process, use alone or together for the control of pregnancy, and any tools, apparatus, devices or other substances that do not perform their main purpose on the human body through pharmacological, immunological or metabolic means but receive assistance from these means" is defined as .
In the published regulation or regulation on the production of medical devices, it determines which products are valued within this scope, the responsibilities of the manufacturers and the conditions that the products must meet before they are released to the market.
- To define the conditions that must be met before medical devices are introduced to the market,
- Establishing conformity assessment procedures according to device classifications
- Monitoring and reporting of existing mechanisms to national authorities to protect public health,
Purpose and Scope of
CE Certificate in Medical Devices
We can summarize the purpose of the Regulation with the following articles:- Specifying the basic criteria that all medical devices or accessories covered by the Regulation should have.
- To prevent the hazards that may arise due to the use of these devices and accessories.
- To establish the necessary rules for ensuring the health and safety of the persons who manufacture, sell, carry, or use the devices.
- The CE Certificate in devices also specifies the procedures and principles for the design, classification, production, launch and use of these devices.
CE Certificate on Medical Devices
within the scope of the Product Classes
There are three different product groups:- Class 1: Products with a low risk group
- Class 2: Products with moderate risk level
- Class 3: Products that are highly risky
All products that fall into Class 2 and Class 3 require the approval of an accredited certification body for CE Certificate. Accredited organizations must also give CE Certificate approval for some of the products that fall into the low-risk product group. For example, for products supplied sterile or used for measurement purposes and specified in the regulation as Class 1s, Class 1m and Class 1r, notified bodies should be applied to the notified bodies when it is requested to obtain CE Certificate in Medical Devices.
Companies are required to apply to the notified bodies appointed under the Medical Devices Regulation (MDR) no. 2017/745 in case of applications (scope expansion, design change, address change, etc.) or initial certification requests that will cause changes to the documents issued under the Medical Devices Regulation 93/42/AT after May 26, 2021.
The Medical Device Regulation published in the Official Gazette dated 02.06.2021 and numbered 31499 (Repeated) has been repealed with Article 110 and the Medical Device Regulation dated 7/6/2011 and published in the Official Gazette no. 27957.
Requirements of the Medical Device Regulation (Medical Devices Regulation No. 2017/745 and regulation of in-vitro medical diagnostic devices 2017/746) published in the Official Gazette dated 2.06.2021 and numbered 31499 (Repeated) regarding post-market supervision, market supervision and supervision, vijilans, iktisadi operators and the registration of devices; in place of the relevant requirements in the repealed Medical Device Regulation (93/42/AT). In order for medical devices covered by the current document to be introduced to the market, no significant changes should be made to the design or intended use.
In order to assess whether a change causes a significant change in design or intended use, the document 'Guidance on significant changes related to medical devices certified under MDD or AIMDD during the transition process with MDCG 2020-3 MDR Article 120' has been published. The Turkish translation of this document has been published on the TİtCK web page.
Whether the changes to the medical devices produced within the company are important will be evaluated according to the MDCG 2020-3 guidance document. If the change is considered not a "significant change" in design or purpose of use, the implementation of this change will be permitted throughout the transition period. However, the document will not be amended as specified in the same guide document.
If it is considered as a significant change according to the guidance document, the implementation of this change will prevent the manufacturer from launching the medical device under the Medical Device Regulation No. 93/42/AT, and will be subject to date 02.06.2021 and 31499 (Duplicate (Medical Devices Regulation No. 2017/745 and 2017/746 in-vitro medical diagnostic devices regulation) published in the Official Gazette.