Medical Devices CE Marking Services!
Medical Device CE Marking signifies a product complies with the minimum requirements for medical device within the European Union. That is a manufacturer’s declaration that the product fulfils the general safety and performance requirements of the relevant European health and safety legislation.
When introducing a product to the market, there are specific requirements that must be met, and obtaining the CE marking is mandatory. Essentially, CE certification is a legal requirement governed by the legislation of the European Union market.
CE marking covers reusable devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes, spanning a diverse range of indications. We have the experience and expertise to prepare technical documentation and submit with any notified body of your choice.
Medical Device CE Marking Requirements!
All the medical device need to have CE marking, but some of the devices need to comply with some requirements. Maybe those devices cannot be CE marked. For example, custom-made devices are different from normal requirements.
They are custom-made for each and every patient. Medical Device CE Marking are different for each class. The simplest devices with less risk are very simple to CE mark but the high-risk class devices need a third party to check any documentation. Once our product CE marked, it can be sold anywhere in the European Union.
The basic process of Medical Device CE marking is needed to identify that product and what kind of regulations are needed for the device. Product risk classification is a very important requirement. The product needs to comply with the general safety and performance requirements, so these are a list of requirements that apply to every medical deviceS.
The medical device manufacturing process needs to be guided by harmonized standards. The conformity assessment procedure needs to be identified. Sometimes some risks are unavoidable, but the benefits will always outweigh the risks. If a manufacturer is outside the European Union, they must apply for medical device CE Marking via an European authorized representative.
Medical Device CE Marking Advantages
Medical Device CE Marking services are mandatory to enter the large European Union market of over 350 million wealthy consumers. Considering the advantages of CE marking, all manufacturers are forced to apply for CE certification, not only in Europe but also in other parts of the world. Large and corporate device manufacturers usually have sufficient staff in the regulatory affairs department.
In the case of small and medium-sized companies that do not have much technical expertise or full-time employees, they are confused and uncertain of what is required to obtain CE mark, including what documents and how much it will cost.
For small and medium-sized companies, it is difficult to prepare technical files because they usually lack knowledge and previous experience for the sizeable tasks involved as per MDR and IVDR documentation. Usually, this gesture and consultant role are vital.
All Non European manufactures must appoint European Authorized Representative
Technical Documentation or Technical File is to demonstrate the safety and performance of medical devices
The European Free Sale Certificate (FSC) or the Certificate of Free Sale (CFS) is the evidence
New MDR & IVDR regulations has made significant changes compared to previous (Directive) classification system
Standard dummy text ever to the since the 1500s, when an unknown the printer took a galley.
NB process EUDAMED is the European Database an IT system proposed by the European Commission
Unique Device Identification (UDI) system helps in device identification and facilitate the traceability of devices.
CE Marking of "Systems" or "Procedure Packs" or "Kits" detailed in MDR 2017/745 article 22
Notified Body process detailing the requirement of the MDR relating to a device have been fulfilled
Usability refers to the user interface characteristic which establishes user learning and user satisfaction,
Medical Devices labelling is complex and needs appropriate information and knowledge how and what