Recently many CE Mark enquiries have emerged in the Hong Kong Market. The CE Mark Certification is a key to export the Face masks to EU Countries. As many face mask production companies have foresee the local market nearly saturated in coming months.
If the medical device is manufactured in the EU country, the manufacturer can apply directly to the local government agency (Competent Authority). If the medical device is manufactured outside of EU, the EU Authorized Representative assists the manufacturer to apply.
Application for CE Mark certification process
Medical masks are medical equipment and need to meet the requirements of the European Union Medical Device Directive 93/42 / EEC and the corresponding standard EN14683. It should be noted that personal protective masks are not medical device, but they must meet the requirements of the EU Personal Protection Equipment Regulations EU2016 / 425 (PPE) and the corresponding standard EN149.
When the types of medical equipment are different, the application process will be very different. The classification of medical equipment is based on the “risk-based” system of human vulnerability, taking into account the potential risks associated with the equipment. This method allows the use of a set of criteria that can be combined in various ways in order to determine the classification. For example: duration of contact with the body, degree of invasion, and local and systemic effects. These standards can then be applied to various medical devices and technologies.
These are called “classification rules” and are listed in Appendix IX of Directive 93/42 / EEC Directive.
In general, the classification of medical equipment:
| Medical Device | Rule Number | Medical Device Classification |
|---|---|---|
| Non Invasive Medical Device | Rule 1-4 | Class Ⅰ / Ⅱa / Ⅱb |
| Invasive Medical Device | Rule 5-8 | Class Ⅰ / Ⅱa / Ⅱb / Ⅲ |
| Active Medical Device | Rule 9-12 | Class Ⅰ / Ⅱa / Ⅱb |
| Special Rule | Rule 13-18 | Class Ⅱa / Ⅱb / Ⅲ |
Class I (sterile / measurement) can be divided into sterile and non-sterile, and measurement is a medical device that measures values
Take a mask as an example
In the market, some manufacturers sterilize face masks with ultraviolet light or ethylene oxide during the production of masks.
CLASS I sterile masks: must be submitted to a third-party (Notified Body) to evaluate and assess products for CE registration.
CLASS I Non Sterile Mask (Non Sterile): There is no need to submit a third-party agency (Notified Body) for evaluation. It is necessary to prepare technical documents and require the assistance of an EU authorized representative.
If the company does not have an ISO 13485 quality management (medical equipment) system, it will take more time to prepare technical documents.
It usually takes three to six months to prepare technical documents, depending on the complexity and type of medical equipment.
Proposed content of medical equipment technical file
1 General information
2 Product description
3 List of harmonized standards
4 List of main specifications
5 Product manufacturing and product inspection plan
6 Risk analysis (according to ISO14971: 2019)
7 Clinical evaluation report
8 Labelling and packaging information
9 Instructions
10 Test, verification, evaluation report
11 Market surveillance
12 Engineering changes
13 Monitoring procedures
14 Product recall procedure
What is an EU authorized representative ?
The authorized representative of the EU is a manufacturer outside the EU country to perform the specific duties required of the manufacturer in accordance with relevant EU directives and regulations. The duties of authorized representatives of the European Union include
Assist manufacturers to register products and notify all EU member states.
Assist manufacturers with necessary monitoring requirements (such as incident reports), and act as a contact point for all EU member states and all communications must be conducted through EU authorized representatives.
The CE Mark and EU Authorised Representative Information must be affixed to the product. The manufacturer signs an EC declaration of conformity to prove that the product meets CE requirements.
Finally, the company’s products with the CE mark can be circulated smoothly in the European market.
If you need further information about CE Mark Certification or mask FDA Certification of Face Mask fees and procedures, please leave contact information info@gabriel.hk / call 2366 4622 for enquiry.
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