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What is Medical Device CE Marking?

CE Marking for medical devices covering 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 with any Notified Body of your choice.

 

Medical Device CE marking means a product complies with the minimum requirements for medical devices 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. If we put a product onto the market, there are some requirements that need to be complied with. That is the CE Mark. It’s mandatory to put the CE Mark on devices. Basically, it’s a law and legislation of the European Union.

Medical Device Testing

Testing is essential to demonstrate General Safety and Performance of the device

European Representative

All Non European manufactures must appoint European Authorized Representative

EN ISO 13485:2016

MDQMS Implementation is mandatory of medium and high risk devices for CE Marking

In-Vitro Diagnostic Regulation

In Vitro Diagnostic Regulation (IVDR) is the new

Technical File

Technical Documentation or Technical File is to demonstrate the safety and performance of medical devices

Clinical Evaluation

MDR article 61 and MEDDEV Rev 4, must be documented and CER

Medical Devices Device CE Marking Process

All the medical devices 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. CE marking is different from 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 get CE mark, the product can be sell anywhere in the Economic European Area.

 

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 device.

 

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 CE Marking via an Authorized Representative.

Medical device manufacturers today are challenged by the regulatory authorities.

You need support to stay and regain CE Certificate validity. That’s where we come in.

Discover how our Medical Device CE Marking services fit for you!

CE (Communauté Européene) Marking of home and hospital patient healthcare devices needs CE Mark Logo is mandatory to enter the European Union (EU) large market of over 350 million wealthy consumers. Considering the advantages of CE Marking for medical devices all manufacturers are forced to apply CE Certification not only from Europe and also from 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 confused and uncertain of what is required to obtain medical device CE Marking 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 sizable tasks involved as per MDR and IVDR documentation. Usually, this gesture and consultant role is vital.

 

>>>  EU Medical Device Regulatory Process as per MDR 2017 >>>

Why Choose Us For Medical Device CE Marking Services?

We are a Premium Regulatory Compliance Solutions Provider for CE Marking / IVDs

To excel and transcend the medical device manufacturers to their utmost level to the new and most awaited Europe's 2017/745 MDR and 2017/746 IVDR

European Free Sale Certificate

The European Free Sale Certificate (FSC) or the Certificate of Free Sale (CFS) is the evidence

MDR & IVDR Classification

New MDR & IVDR regulations has made significant changes compared to previous (Directive) classification system

MDR & IVDR CE Marking Timeline

Standard dummy text ever to the since the 1500s, when an unknown the printer took a galley.

MDR & IVDR Notified Body List

MDR & IVDR Up-to-date information of notification status of Notified Bodies can be found

EU Registration (EUDAMED)

NB process EUDAMED is the European Database an IT system proposed by the European Commission

Unique Device Identification (UDI)

Unique Device Identification (UDI) system helps in device identification and facilitate the traceability of devices.

Systems and Procedure Packs

CE Marking of "Systems" or "Procedure Packs" or "Kits" detailed in MDR 2017/745 article 22

Vigilance Control System

Manufacturers legally obligated to report serious incidents and Field Safety Corrective Action as per MDR Section 2, article 87.

Sterile Medical Devices

NB process detailing the requirement of the MDR relating to a device have been fulfilled

Medical Device Usability

Usability refers to the user interface characteristic which establishes user learning and user satisfaction,

Medical Device Labeling

Medical Devices labelling is complex and needs appropriate information and knowledge how and what

General Safety & Performance

EU MDR replaces the essential requirements (ER) by general safety and performance requirements

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Do you have questions about CE marking for medical devices? Contact us today, we’re here to help.