Certification - Medical Devices
CE Mark Approval for Medical Devices
What is a CE Mark?
Before a medical device can be launched in the European Economic Area (EEA), it must receive a CE mark. The CE mark confirms that the medical device complies with the essential requirements of applicable European Union (EU) Medical Device Directives (MDDs). It also shows that the medical device can be freely marketed anywhere in the EEA without further control.
CE marking is mandatory, even if the medical device was manufactured outside the EEA. It is the manufacturer’s sole responsibility to obtain and place the CE mark on the product. If the product is imported from outside the EEA, then this responsibility falls to the importer within the community.
CE marking is performed by EU approved notified bodies that are listed in the New Approach Notified and Designated Organizations (NANDO) database.
- What is the requirements of CE Marking?
- Benefits of CE Mark
What is the requirements of CE Marking?
In order to obtain CE Marking, manufacturers shall demonstrate the conformity of their medical devices and the related production system. The following steps are to be taken by the manufacturer:
1) Classification of the device:
Manufacturers must classify their device in order to identify the type of risk and adopt the resulting marking procedures for the different classes.
Medical devices are classified into 4 main categories:
- Class I
- Class IIA
- Class IIB
- Class III
The risks are elevated from Class I to Class III, thus the conformity assessment route gets heavier in accordance to that.
Class I devices have 3 sub categories which include:
- Class I devices neither have measuring function nor sterilized: Notified body (NB) involvement is not mandatory for this type of products. The manufacturer may prepare their technical file, bear the CE marking on the product and market it. There should be no notified body ID number below CE mark as no any notified body involve to conformity assessment.
- Class I devices which have measuring function: Notified body shall be involved for this kind of device. the conformity assessment route is Annex V, but limited to metrological aspects.
- Class I devices which are terminally sterilized: Notified body shall be involved for this kind of device. The conformity assessment route is Annex V, but limited to sterility aspects.
Class IIA devices. NB involvement is mandatory. Conformity assessment route is Annex V.
Class IIB devices. NB involvement is mandatory. Conformity assessment route is Annex II (excluding section 4)
Class III devices. NB involvement is mandatory. Conformity assessment route is Annex II (including section 4).
2) Submission of Technical File/Dossier for Review:
Medical device manufacturers must prepare Technical Files of Technical Dossiers for each of its devices which is then to be submitted to NB for review. Technical file includes following sections in general:
- Manufacturer name, address, subcontractor name, address.
- Product definition (intended use, GMDN code, models, sizes, sterile or non-sterile, single use or reuse, etc.)
- Technical drawings
- Instruction for use (IFU)
- Packaging configuration
- Manufacturing Flow Chart
- Quality Control Plan
- Validation Files and Validation Master Plan
- Post Market Surveillance Plan
- Risk Management File
- Clinical Evaluation report
- Pre-Clinical evaluation report (biocompatibility test, biological test, physical test, chemical test, electrical test etc.)
- Stability studies (accelerated aging reports, real time aging reports)
- Essential requirement checklist
- Declaration of ingredients
3) Medical Device Quality Management System verification:
Upon review of the technical file of each device of a manufacturer, the NB shall conduct an audit for verification of the compliance of the Medical Device Quality Management System of the manufacturer against the ISO 13485.
4) Produce a Declaration of Conformity:
The manufacture shall prepare a Declaration of Conformity which is a legally binding document stating that the device is in compliance with the applicable Directive and place the CE Mark on the product.
Benefits of CE Mark
- Immediate access to all EU and EEA Markets without any restrictions as well as any other international markets where CE Marking is accepted.
- Improved efficiency resulting from a streamlined quality management system
- Gain consistent and effective control of key processes.
- Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA as well as other international markets where CE Marking is accepted