Quick Contact
What is CE Mark Certification?
CE Mark certification is very important requirement if company want to sell medical devices and IVD devices in Europe area called European Economic Area (EEA). CE Mark show that product follow safety rules and performance rules given by European law. We provide CE Mark service for the following rules
⇒ Regulation (EU) 2017/745 – Medical Device Regulation (MDR)
⇒ Regulation (EU) 2017/746 – In Vitro Diagnostic Regulation (IVDR)
These regulations are strict. Manufacturer must show that device is safe, working properly, risk is controlled, quality system is maintained, and also company must monitor device after selling in market. I3CGlobal helps medical device manufacturers and IVD manufacturers to get CE Mark certification. We guide companies in full process like device classification, regulatory strategy, preparing technical documentation, and coordination with notified body.
Different from many CE consultants who work with many industries, our service is only for medical devices and IVD devices. Because of this we have strong and special knowledge in medical device regulations. We do not provide CE Mark certification services for other product categories such as Machinery, Electrical equipment, Construction products, Consumer electronics and Industrial products
When a product get CE Mark, manufacturer can legally sell the product in European Economic Area (EEA). For medical devices and IVD devices, CE Mark Certification show that device follow General Safety and Performance Requirements (GSPR) under MDR or IVDR regulation. With CE Marking Certification, manufacturer can:
⇒Sell product in EU market
⇒Show that device follow EU regulatory rules
⇒Create trust with doctors, hospitals, and patients
⇒Enter one of the biggest healthcare markets in the world
But now getting CE Mark for medical devices is more difficult. After MDR and IVDR regulations started, requirements became more strict and documentation work is much more.
Why Work With Experienced CE Marking Certification Regulatory Consultants
CE Mark Certification requires deep knowledge of regulatory requirements, harmonized and non harmonized standards, MDCG Guidelines, technical documentation, and clinical evidence consolidation. Experienced regulatory consultants can help manufacturers:
-
Avoid common documentation mistakes
-
Prepare Notified Body compliant technical files
-
Reduce certification delays
-
Navigate MDR and IVDR requirements effectively
I3CGlobal have extensive experience working with medical device and IVD manufacturers and supporting them through the CE Marking certification process.
CE Mark Certification for Medical Devices (MDR 2017/745)
Medical devices sold in European Union must follow rule called Medical Device Regulation (MDR) 2017/745. Device also must have CE Mark on it before selling. MDR rules are more strict than old rule called Medical Device Directive (MDD). Now manufacturer must show more clinical evidence, better risk control, and plan to check device performance even after selling in market.
Medical Device Classification under MDR
Medical devices are classified based on their risk level.
-
Class I – Low risk devices
-
Class IIa – Medium risk devices
-
Class IIb – Higher risk devices
-
Class III – High risk devices
This classification decide how much checking is needed and whether Notified Body must check the device before approval.
Key Requirements for MDR CE Mark Certification
To obtain CE Mark Certification under MDR, manufacturers must prepare several regulatory documents and systems. These include:
-
Technical Documentation
-
Clinical Evaluation Report (CER)
-
Risk Management File
-
Usability Engineering File
-
Post Market Surveillance Plan
-
Post Market Clinical Follow-up (PMCF)
-
Quality Management System (ISO 13485)
-
Declaration of Conformity
For many device classes, Notified Body must review the documents and device. Only after that manufacturer can put CE Mark on the device and sell in Europe.
CE Mark Certification for In Vitro Diagnostic Devices (IVDR 2017/746)
In vitro diagnostic devices are regulated under IVDR 2017/746, which replaced the previous IVDD directive. IVDR introduced a new classification system and significantly increased regulatory scrutiny. Many IVD devices that previously self-certified under IVDD now require Notified Body involvement.
IVD Device Classification under IVDR
IVD devices are classified into four risk classes:
-
Class A – Low risk devices
-
Class B – Moderate risk devices
-
Class C – High risk devices
-
Class D – Highest risk devices
Class A devices may be self-certified (except sterile devices), while Class B, C, and D devices require Notified Body assessment.
Key Requirements for IVDR CE Mark Certification
Manufacturers must prepare extensive documentation including:
-
Technical Documentation
-
Performance Evaluation Report (PER)
-
Scientific Validity
-
Analytical Performance Data
-
Clinical Performance Data
-
Risk Management Documentation
-
Post Market Performance Follow-up (PMPF)
-
Quality Management System (ISO 13485)
IVDR compliance requires strong scientific and clinical evidence to support device performance.
Get Expert Support for CE Mark Certification
If you are medical device or IVD device manufacturer and planning to enter European market, getting CE Mark certification is very important regulatory step. Good planning, strong documentation, and regulatory knowledge are needed for successful certification.
Our regulatory consulting team helps manufacturers prepare required documents and guide them through CE Mark certification process under MDR and IVDR. You can contact our regulatory experts to discuss how we can support your CE certification process.
Role of Notified Bodies in CE Mark Certification
Notified Bodies are independent organizations approved by EU member states to check medical devices and IVD devices quality and performance. For higher risk devices, manufacturer must get CE mark certification from a Notified Body before selling the product in the EU market. Notified Bodies check the following sections like:
⇒Technical Documentation
⇒Clinical Evidence
⇒Quality management system
⇒Risk management Activities
They may also do audit of manufacturer facility to see if company is following regulatory rules. Because number of Notified Bodies under MDR and IVDR is limited, getting certification may take long time. So good preparation of documentation is very important.
Challenges Manufacturers Face with CE Mark Certification
Many manufacturers think CE Mark certification is simple. But under MDR and IVDR it is not easy. Process has become more complex and needs strong documentation. Some common problems manufacturers face are:
⇒Preparing full technical documentation
⇒Showing enough clinical evidence
⇒Understanding new regulatory requirements
⇒Working and coordinating with Notified Bodies
⇒Maintaining proper quality management system
Now regulatory rules are more strict and documentation requirement is much bigger than before. CE Mark certification is very important step for medical device and IVD manufacturers who want to sell products in European market. But MDR and IVDR rules made the process more demanding.
Manufacturers must prepare large technical documentation, collect clinical evidence, implement quality systems, and work with notified bodies during certification. Because of this, many companies take help from experienced regulatory consultants. Experts can guide manufacturers through the complex requirements and help achieve CE Mark certification faster and correctly.
Frequently Asked Questions
Can a company outside Europe obtain CE Mark certification?
Yes. Manufacturers located outside the European Union can obtain CE Mark certification. However, they must appoint an Authorized Representative in the EU. All requirements are same for domestic and foreign manufactures
How long does CE Mark certification process take for medical devices and IVD,s?
The timeline can vary depending on device classification and documentation readiness. In many cases, the process may take 6 months to 18 months, especially if a Notified Body review is required.
What is a Quality Management System for CE Mark certification?
Manufacturers must implement a Quality Management System, based on EN ISO 13485:20XX, to ensure consistent design and quality