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Medical Device CE Marking Services!

We support you throughout the Medical Device CE Marking Process and never leave you in the dark. Recognized by over 800 manufacturers, Team I3CGLOBAL is considered the best and most economical regulatory service provider for CE Marking compliance. We have the necessary resources and skills to take up any type of device.

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Medical Device CE Marking

Medical Device CE marking is a legal requirement for placing a device on the market in the European Union. Affixing a CE Mark to the product signifies that it meets the GSPR of all relevant European Medical Device Regulations. CE Mark issued by Notified Bodies gives the authority to manufacturers to affix the CE Logo on the medical device and its packaging.

 

We are regulatory professionals who guide on specific requirements that must be met and obtain the medical device CE Marking. The medical device industry generally covers reusable devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes, spanning a diverse range of indications and state-of-the-art features.

 

We have the experience and expertise to prepare CE Marking Technical documentation covering core sections such as risk analysis, clinical evaluation, usability, etc. and submit it to any notified body of your choice.

We specialize in providing Medical Device CE marking documentation and audit support for obtaining CE Certificate in the shortest time and lowest expenses.

Step-by-Step Guide to CE Marking Process

All medical devices need to have CE mark on it, but some of the devices need to comply with some requirements. Maybe those devices cannot be CE marked. For example, drug-device combination products that need NBoP are different from normal requirements.

 

CE Marking requirements are slightly different for each class and rule. The simplest devices with less risk are simple to CE mark but the high-risk class devices need a third party to check any documentation. Once our product CE is marked, it can be sold anywhere in the European Union.

 

The basic process of CE Mark starts with identifying the device, models, variants, accessories, consumables and what kind of standards are needed for the device. Product risk classification is also an 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 must align with product-specific standards and harmonized standards. The conformity assessment procedure or the route of CE marking needs to be identified. Sometimes some risks are unavoidable, but the benefits will always outweigh the risks and it should be justified with supporting evidence.

 

If a manufacturer is outside the European Union, they must appoint an EU Authorized representative before applying CE Marking via a notified body.

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Why CE Marking is Essential? Ensuring MDR Compliance and EU Market Access

Medical Device CE Marking is mandatory to sell in the European Union market of over 350 million wealthy consumers. Considering the advantages of CE Mark, 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 a medical device 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 technical documentation. Usually, this gesture in a CE Marking consultant role is vital.

CE Marking and EU MDR 2017/745 Key Compliance Requirements

The Medical Device Regulation MDR 2017/745 replaces the old MDD 93/42/EEC. This means that the MDR, which came into effect in May 2017 and came into force on May 26, 2022, supersedes the MDD as the regulatory framework for medical devices in the European Union. Being a European regulation, it automatically applies to all EU Member States and the European Free Trade Association.

 

The core sections of the MDR 2017/745 includes:

 

  • Scope and Definitions
  • General Requirements for Medical Devices
  • Medical Device Classification
  • Conformity Assessment Procedures
  • Designate a Person Responsible for Regulatory Compliance
  • Implement a Quality and Risk Management System
  • Requirements for Technical Documentation File
  • Conduct a Clinical Evaluation
  • Post-Market Surveillance, Vigilance, and Market Surveillance
  • Assign a European Authorized Representative (if Applicable)
  • Obtain CE Certification by a Notified Body
  • Prepare a Declaration of Conformity
  • European Database on Medical Devices (EUDAMED)
  • Unique Device Identification (UDI)
  • Affix a medical device CE Marking
  • Maintain Post-Market Surveillance
  • Transitional Provisions

 

As a trusted regulatory partner, I3CGLOBAL offers comprehensive EU MDR consulting services ensuring early medical device CE Marking.

We are a premium CE Marking regulatory compliance solutions provider for medical devices.  If you require additional technical support and expert manpower to develop a technical file and coordinate with the Notified Bodies; That’s where our role comes in!!

CE Marking Consultants Role in Ensuring Compliance and Streamlining CE Certification

We pride ourselves on being a top-tier provider of medical device CE Marking, with a primary focus on offering quality manpower and expert advice. In today’s complex MDR rules, manufacturers encounter numerous challenges from notified bodies. These challenges necessitate additional technical support and expert manpower to effectively navigate interactions with notified bodies and uphold the ongoing validity of CE certificates. This is precisely where our expertise shines

 

Our dedicated team of professionals is equipped with the knowledge and experience to provide manufacturers with the necessary guidance and assistance at every stage of the MDR 2017/745 technical documentation and certification process. From initial development to engagement with notified bodies and ongoing interaction and file updation, we ensure that our clients are well-implemented to meet and exceed MDR 2017/745 requirements, thereby facilitating early medical device CE Marking and entry into the EU market.

Frequently Asked Questions

CE Marking deadline under MDR extended.

The original schedule for 26 May 2024 was extended to 31 December 2027  for a few devices and 31 December 2028 for another set of devices based on the risk class of the device. More details>>

CE Marking and Manufactures benefit

Some of the benefits of CE mark are the following:

  • Demonstrates to buyers and patients the essential EU legal requirements are met.
  • Allows marketing of the device in all 30 member countries of the EEA.
  • The majority of the Asian, African, Middle East and Latin American countries accept CE mark, to register in the respective countries.
  • Indicates your device meets safety and quality regulations and standards.
  • Attract Distributors and OBL/PLM manufacturers.

Explain medical device CE Marking with Drug.

Drug Device combination products must follow MDR Article 117 with the involvement of the notified body in the form of NBoP. More details>>

Is systems and procedure packs possible to CE Certify?

Yes, As per EU MDR 2017/745 systems and procedure packs are to be CE Certified according to Article 22.