EU CE Marking Consultants For Medical Device

In the dynamic and highly regulated landscape of the medical industry, obtaining regulatory approval is essential for bringing products to market. For companies seeking to sell medical devices within the European Union (EU), achieving CE marking is a critical milestone. CE marking signifies compliance with EU health, safety, and environmental protection standards, ensuring that products meet stringent requirements.

At CERT3Global, we specialize in providing comprehensive EU CE marking services tailored specifically for medical companies and manufacturers, guiding them through the intricacies of regulatory compliance and facilitating successful market entry.

It is a mark that appears on products that are sold in the European Economic Area [EEA], it serves as an indication that the product has been assessed and meets the EU standard of safety, health, and environmental protection requirements.

The product can be manufactured anywhere in the world and can be marketed in the EU after the mark.

For Example during the COVID pandemic in Europe, lots of infrared thermometers were placed in the market. Regardless of the country of origin, the CE mark indicates that the product complies with EU regulations and ensures confidence in suppliers and the public. It is the Manufacturer’s responsibility (It is a self-declaration) to carry out conformity assessment, set up the technical file, issue the EU declaration of conformity(DoC), and affix the CE marking to a product.

CE Marking Consultants

Cert3global is a leading CE marking Consultancy Provider. Using our regulatory expertise and experience, we have helped many clients, making sure they comply with EU regulations.

We assist in the complete CE marking process right from the preparation of technical documentation and working closely with clients to personalise our service and provide strategies to help them achieve maximum sales.

Why is EU CE Marking Required?

Indicates that the medical device:

  • Is a safe and high-quality product for the patient.
  • Has undergone risk assessment processes and is a safe and high-quality product for the patient(consumer).
  • Meets EU safety, health, or environmental requirements.[under the MDR/2017]
  • Gives confidence to suppliers and businesses that the device can be traded throughout the EEA(European Economic Area)
  • The device meets the general safety and performance requirements (GSPR)

Important Note:

A CE marking does not indicate that a product has been approved as safe by the EU or by another authority. It does not indicate the origin of the product either.

Additional Information on EU CE Marking

Overview of Steps of Obtaining a CE Marking:

Here is a brief overview of the Steps involved in obtaining a CE Marking. [Click here to know about MDR (Medical Device Regulations) for a detailed and updated process]

1) Appoint a Designated Individual Manufacturers must have at least one member responsible for regulatory compliance and he/she needs to have relevant expertise in the field of medical devices.

2) Determine the Classification of your device The MDR has established rules to classify medical devices according to risk level, placement on the body, and duration of use.
Risk – devices are categorized in Class I, IIa, IIb, and III (increasing order of risk)
Body placement – Devices can be ‘invasive’ or ‘non-invasive’ (depending on their level of penetration in the body) For example, the hearing aid is a non-invasive Class II device placed on the body’s surface. On the other hand, a Deep brain stimulator is an invasive  Class III device.
Duration of Use – Transient use of up to 60 minutes, short-term use of up to 30 days, and it becomes a long-term period above that time period.

3) Implement a Quality and Risk  management System ISO 13485:2016 is chosen by most medical device manufacturers because it is presumed to be in conformity with MDR requirements regarding QMS. The QMS must include Clinical Evaluation, Post Market survey (PMS), and Post Market Clinical Follow-up (PMCF)

4) Prepare Technical Documentation (also ‘medical device technical files’) as per Annex II and III of the MDR It is a requirement of MDR and should contain detailed information regarding the device lifecycle. Design Dossier (Design Control) contains info regarding a device’s physical characteristics and construction. A crucial process is the Design Control or Design Dossier, which contains proof that the device was designed in a way to minimize risk, injuries, or accidents.

5) Appoint an Authorised Representative (EC REP) If the medical device manufacturer is not based in the European Economic Area (EEA), they need to appoint an Authorised representative in the member country to:

  • Obtain a Single Registration Number from the regulators via EUDAMED.
  • Get technical documents verified
  • Inform the manufacturer  about complaints
  • Address their documentation inside Europe

6) Notified Body Independent Assessment and Certification (If Required)

  • A notified body is an organization designed to address the conformity of products before their placement on the market and is responsible for auditing and certifying manufacturers concerning the conformity of devices with MDR.
  • They need not asses manufacturers of class I non sterile and no measuring devices, companies can issue a self-declaration of conformity.
  • For other (higher) classes, certification is mandatory and has a maximum validity of 5 years.
  • Manufacturers receive a certification from the Body once the audit is done.
  • Audits and assessments occur periodically to ensure the approved QMS (Quality Management System) and Post Market Surveillance are being applied by the company.

7) Preparation of DoC [Declaration of Conformity] By Annex IV of MDR, a DoC is a legally binding document prepared by the manufacturer stating that the device complies with applicable European Requirements.

8) Register Your Device Under a Unique Device Identifier [Note: It is an additional requirement ] To facilitate the tracing of medical devices, a UID is a unique number or alphanumeric code stored in the European Database on Medical Devices [EUDAMED]. It needs to be assigned individually to specific device models.

9) Affix CE Marking to the Medical Device Must be affixed to the device itself, packaging, and on any instructions for use. It is crucial for marking to be visible, legible, and made with non-washable material.

10) Maintain a Post Market Surveillance

  • Before obtaining a CE Marking and placing a medical device into the market, manufacturers need to prove that a post-market surveillance system is already in place to address questions and complaints.
  • This ensures proactive actions in case of Product recall implementation, identifies risks, and addresses consumer complaints.

What is the Validity of CE Marking?

There is no official period of validity for the CE Marking.However, the EU Declaration of Conformity (DoC) which is essential for it should be kept up to date. If there is any change in the DoC, then the version of the declaration must be updated. For example, changes in the official contact details of the manufacturer.