The certification mark is a specialized type of trademark that is used for indicating that certain goods or services have met certain prescribed standards. A certification mark can be represented by names, symbols, marks, etc for goods and services, and it does not differ between either of them.
The new MDR 2017/745 will come into effect in May 2020, by which all manufacturers who have been following MDD and AIMD should switch to this new regulation. The procedure to obtain the CE certification under new MDR are as follows;
Initially, the manufacturer should classify the medical device by determining the set of regulation that applies to the device subject to Medical Device Regulation ( MDR 2017 / 745) or In Vitro Diagnostics Regulation (IVD 2017 / 746). Annexure VIII of the MDR will classify the medical device depending upon the risk factor. Here the classification pertains to the time scale of contact with patients, a degree of the meddling of the device, and its effect on different parts of the human body, by use of this device.
The QMS is an essential and global requirement to enter into the medical device sector. The European Commission has sorted out the QMS for medical devices, which is required to enter into the EU market. The quality management system will consist of the procedure and policies that should be carried out by the workers daily to ensure the manufacturing processes are safe and reliable.
Once the classification of the medical device and enforcing the QMS at the organization is over, the next best thing is for the device to meet the conformity requirements of the MDR. Depending on medical device classes like the class I, class IIa, class IIb, class III, the technical file should be produced concerning the conformity of the medical device. This technical file includes;
The class III device should enclose the illustration about the design of the product along with this technical file.
Once the above procedure has been accomplished, the QMS and documentation of the organization will be audited by the notified body. The notified body is a third party body, which conducts the audit of medical device manufacturing companies and certifies that the medical device produced by them meets the standards required by the MDR/ IVDR.
After the medical device has passed the audit, the CE certification will be issued to the product along with the ISO 13485 certification, which confirms that the QMS complies with the European standards. Finally, the declaration of conformity, which is a legal document proclaims that the medical device meets all the required standards by the MDR/ IVDR and that the CE certification can be affixed to the medical device.
As the CE certification is a well-known certification mark among the public, the organization, which mentions the CE certification mark on products, will have an additional advantage to conduct business without facing any restrictions on the European Economic Area (EEA).
The CE certification will ensure consumers that the products are tested, and are reliable, concerning manufacturing, customer safety, quality, etc.
The manufacturers need not worry about too many restrictions, such as the CE certification mark, is the only standard requirement. By following the product directives, it is easy to apply and achieve conformity.
Apart from the standards required by the product directives of the EU, some appropriate directives can be self-declared by the manufacturer for conformity, which should not contradict with the EU directives.
By carrying out the regulations prescribed by the EU, there will be very reduced damages and errors in the product thereby the liability of the manufacturer will be decreased in the European market.
Any manufacturer from the world can make or sell his/her products inside the European Economic Area (EEA) after meeting the prescribed standards of the EU product directives. As the CE mark is the only certification required by the European market, the manufacturer will not face any hurdles in obtaining the certification. The certification mark imprinted on products ensures consumers that the respected goods fulfill the standards required by certifying authority or organization.
As the CE marking is proof that the product meets the high safety, health, and environmental protection standards set by the EU. The importer should ensure that the product has the correct CE certification mark or not. It is irrespective that the product was manufactured inside or outside the EEA, if the wrong or fake CE certification has been imprinted on the product then it is considered as an offense and subject to punishment. Hence, a checklist will help in sorting out the most important things.
According to the EU legislation, the EU directives have separate directives for each product group and various classes, more than one directives can be placed for the same product group. For instance, electrical products fall under the EMC, and RoHS directives.
The manufacturer is accountable for testing the products and checking the essential requirements of the directives that should be met. Most importantly, the risk assessment should be executed in the above procedure.
The technical documentation will be scrutinized by the market authority if required. Here, the technical documentation includes specification, inspection certificates, drawings, test reports, manuals and the declaration of conformity. If products are imported from outside the EEA, then the importer should make sure that the foreign manufacturer must produce the technical documentation of the product, if requested, by market authorities. Similarly, the manuals should be written in the language where the product is sold.
The manufacturer should ensure that the CE mark is mentioned on the products after the assessment process is over. If the notified body has conducted the production phase, then the corresponding body’s identification number should be mentioned on the products. Finally, the declaration of conformity should be signed thereby taking the responsibility for the conformity of the products and should be included in the technical documentation. For some product groups, this proof of declaration should be enclosed while supplying the products to customers.
The AGMARK is a quality certification mark and it ensures the quality and purity of agricultural products. The directorate of marketing and inspection impose the agricultural produce act, 1937, which prescribes the standards met by the agricultural products to obtain the AGMARK certification. These standards are harmonized with international standards by interpreting WTO requirements. Products which comes under the AGMARK certification are;
ISI stands for the Indian Standards Institute, which was established to create a standard and to maintain the quality of the industrial product production. This certification mark ensures that the products have met the standards determined by the ISI. Nowadays, this certification is issued by the Bureau of Indian Standards (BIS) concerning the legislation of 1986. The ISI mark can be obtained mandatorily and voluntarily. However, certain products are mandatory to obtain the ISI mark! They are LPG cylinder, fertilizers, packaged drinking water, electrical appliances, steel products, cement, batteries, etc.
The BIS Hallmark certification denotes the purity of the gold and silver in India. This mark was introduced in the year 2000 for gold and 2005 for silver. Recently in January 2020, the ministry of consumer affairs mandated that all jewelry makers are to acquire the BIS hallmark certification on gold jewelry, within a year’s time i.e by 2021. The objective of mandatory hallmarking is to protect the consumer from being cheated by the manufacturer and obligating the manufacturer to maintain the standards of purity.
The CE certification should be marked on the following products
The first and foremost step is to identify whether a product is eligible to obtain the CE certification or not. The reason is not all products are obliged to receive the CE mark. Certain selected products fall under the scope of any EU product directives and hence required to affix the CE mark.
Each directive has a unique essential requirement that has to be met by the product and it depends upon the classification of the products. These essential requirements are in par with the Harmonised European Norms (HENs).
There are different conformity assessment modules sorted out by the directives for each product. The various modules available are
The products having minimal risk can be self-certified by the manufacturer by enclosing the declaration of conformity. But the products with greater risks are to be independently certified by the notified body, which may be a private sector organization or government body nominated by the member government.
The notified body follows the procedure laid down by the product directives and performs all tests on independent labs. The manufacturer can choose a notified body, which is enlisted in the official journal published by the European Commission.
The notified body performs the following functions:
Similarly, a certain set of directives require the manufacturer to assign the authorized representative in the European Union to produce the technical documentation.
The product directives mandate the manufacturer to prepare the technical documentation of the products. This document contains information related to test reports and compliance standards of the products.
The manufacturer, importer, and authorized representative should enclose the declaration of conformity of the products once they are satisfied that their products comply with the standards of the directives. Some products are required to be registered in the EU ex: class I medical devices. Without this registration, these products are not allowed to affix the CE mark. After the aforementioned process is over, affix the CE mark on the product and provide them in the market for sale.
The documents required for obtaining CE certification mostly include the technical documentation and declaration of conformity of the manufacturer.
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