Currently, the demand for masks in Europe is very large. There are many types of Masks used. This means that there are many standards for each different type of Mask.
We would like to give some information about the regulations as follows:
THAT CUSTOMERS SHOULD NOTE THE FOLLOWING:
- Need to categorize your medical mask products clearly
- CE certification is only one of the basic conditions for exporting to the EU
- Some types or on request for special masks; Businesses need to test according to EN 14683 or EN 149
Present; to be able to quickly implement CE certification for customers. classification Masks are medical masks for general use. Classified in Class I Medical Device Directive 93/42/EEC.
CE certification does not include test results according to EN 14683 or EN 149.
MEDICAL DEVICE INSTRUCTIONS (93/42 / EEC)
The Medical Device Regulation (MDR) came into force on 26 May 2017. The MDR will replace the current EU Medical Devices Directive (93/42/EEC) and the EU Directive on Medical Devices. active implantable medical device (90/385/EEC).
Manufacturers of currently approved medical devices will have a three-year transition period until May 26, 2020 (application date) to meet the requirements of the MDR. The new MDR provides additional time after the application date that allows placing new products under the maximum MDD. 4 more years on the market. Additional requirements and limitations will apply for this extended transition period.
The European Union (EU) Directive 93/42/EEC (also known as the Medical Devices Directive – MDD) details manufacturers and importers Essential requirements that must be met to apply CE marking and legally market or sell their equipment in the EU. Because there are many types of devices covered by MDD, the specific requirements depend on the device's classification and intended use. However, in most cases the use of an EU Notified Body is necessary to assess Directive compliance before CE marking can be applied to equipment.
WHAT IS A MEDICAL DEVICE?
A medical device is any instrument, device, or device used to diagnose, monitor, or treat disease, injury, or disability in humans. The term “medical device” applies to a wide range of products, devices, and devices, from simple tongue pain relievers and bed sheets to laser surgical devices. Medical devices may also include some electronic radiation emitting devices with medical applications, including ultrasound devices and X-ray machines.
Although the term is widely applied, medical devices should not be confused with other groups of products used to treat medical conditions. For example, drugs and pharmaceutical preparations, which treat medical conditions through chemical action or metabolism by the body, are not considered medical devices and are subject to different regulations and requirements. .
STEPS CERTIFICATION OF MEDICAL MAKEUP MAKETING – CLASS I DIRECTIONS 93/42/EEC
Must repeat so that the business can grasp the information. We will perform CE marking for mask products according to classification Class I Directive 93/42/EEC. We will not perform EN 149 product testing with this Class I product.
In case, Customer's products need to be tested according to EN 149 . standard; We will support communication and sending samples to laboratories around the world. (Note: Currently in Vietnam, there is no Lab that can test the above standard)
The steps to achieve Class I Directive 93/42/EEC medical mask certification include basically the following steps:
STEP 1: Identify the EU Directive and Classification of Medical Masks:
Businesses need to identify and classify medical masks according to the Medical Device Directive. Specifically here is the Medical Devices Directive (93/42 /EEC). Most devices fall under Medical Device Directive 93/42/EEC, but some high-risk implants are subject to Active Implantable Medical Devices Directive (AIMDD) 90 /385/EEC. In vitro diagnostic directive (IVDD) 98/79/EC applies to IVD.
Basically, all medical devices fall into four basic categories:
- Non-invasive (non-sterile) device
- Invasive medical devices
- Active medical equipment
- Special rules (including contraceptive diagnostic medical devices, sterilization and radiology)
Devices are segmented into the classes noted below.
- Type Ia Supplied non-sterile or without measuring function (low risk)
- Type Ib – Supplied with sterile and/or measuring function (low/medium risk); MDR adds to this group, reusable surgical instruments such as Class I reusable surgical instruments.
- Class IIa (medium risk)
- Type IIb (medium/high risk)
- Class III (high risk)
Medical masks in Vietnam are usually classified into Class I. That is, type : non-sterile.
The classification of medical devices is based on the 18 principles in Appendix IX of the MDD.
THIS IS THE CHEAPEST WHAT ENTERPRISE NEED TO KEEP WHEN DETERMINING PRODUCTS AND PRODUCT USE PURPOSE.
STEP 2: Drafting technical documents for CE marking as required by the Directive
The CE Marked Specification or Design Profile (Class III) is a comprehensive description of the product. Records are intended to demonstrate compliance with the requirements of the European Directive. The development of product specifications is an important step in the CE Marking process. Records should ensure compliance with European requirements and Medical Device Directive 93/42/EEC.
Request technical records to certify CE
Your profile or technical profile includes detailed information about the design, function, composition, uses, requirements, and clinical evaluation of your medical device. They are required for all device types (Class I,, I Sterile, IIa, IIb and III).
Technical documents will be verified and reviewed by the competent authority.
- Business Registration
- Product description;
- Packaging, product label samples. Note: need to provide the brand of the product. Because CE marking will mark each product
- Test results (if any)
Technical documents must be written in the language of the country the product is to be exported. Normally this Technical Profile will be compiled in English.
STEP 3: Submit your application to the Certification Body in Europe – Representative Agency
Basically in CE marking for Class I medical devices. EASYManufacturers in non-EU countries will have to appoint or choose one party to represent them in Europe.
As a certification body. Certification bodies will confirm that your products meet the requirements of the European Directive. When they confirm or issue CE certification to Customer. They are also the representative and responsible for the Customer's Product that has met the requirements under the Directive.
ALSO ENTERPRISE CAN CHOOSE THE NB NOTIFICATION AGENCIES (EU Authorized Notification Body).
Normally these NB notifiers issue CE only for CLASS I b products; Class II; III. However, enterprises can still choose this organization for certification. Costs are often higher than conventional certification bodies
IS THE CERTIFICATE ORIGINAL AUTHORIZED BY EUROPE ?
1. The CE marking is basically that the Enterprise/manufacturer must carry out the CE marking.
Enterprises choose the appropriate evaluation method. Enterprises can prove that their products meet EU requirements. Eligible for CE marking. It is the responsibility of the manufacturer to carry out the conformity assessment, to establish the technical profile, to issue the EU declaration of conformity and to affix the CE marking to the product. According to regulations of the Law; In cases where the law requires Enterprises to choose an assessment agency (authorized by Europe). But we must know.
2. Class Ib, Group II medical device products require these authorized review bodies.
These agencies also only carry out CE certification for Class Ib medical device products; Class II and above.
According to instructions Directive 93/42/EEC on Medical devices (MDD) stated”
Medical devices classified under the provisions of Annex IX of the MDD are class I 0 Class I (low risk), type IIa or IIb (medium risk) or type III (high risk).
AND THIS IS THE PROBLEM OF ANSWERING CUSTOMERS' QUESTIONS
Participation of the EU Authorized Notifier Body is not required for Class I (Class I) medical devices. unless they have a measuring function or are marketed under sterile conditions.
We have classified the products of Masks for customers as: Class I – Non-sterile type.
Therefore only certification bodies can represent Clients in Europe. They will be the ones to confirm that the Technical Files (Customer's Technical File ...) meet the requirements according to Ms. Thi.
CE CERTIFICATE OF THE CERTIFICATION ORGANIZATION