In May 2004, the European Union added ten new member states, plus the original 18 member states, the European Union currently has 28 member states, the European Union is an increasingly large single market. Domestic manufacturers of in vitro diagnostic medical devices also realize this point, but this market is a threshold, the threshold is the CE certification. Domestic manufacturers are relatively new to this, doubly difficult, this article on the main steps to apply for CE marking slightly introduced.
The first step to determine whether the product is an IVD
Manufacturers should first determine whether the product is an in vitro diagnostic medical device according to the definition of in vitro diagnostic medical device, according to the definition of the European Union In Vitro Diagnostic Medical Devices Directive 98/79/EC, in vitro diagnostic medical device is defined as: any reagent, calibrator, control substance, instrument, apparatus, device, equipment or system A medical device, whether used alone or in combination, which has been designated by the manufacturer for the purpose of in vitro testing of samples, including blood and tissues, taken from the human body, and which is used alone or principally to provide information relating to:
* Physiological or pathological conditions
* or congenital anomalies
* or to determining the safety and compatibility with a potential recipient of a transplant
* or to monitoring the efficacy of a treatment. p>* or to monitor the effectiveness of treatment.
Sample containers are also considered to be in vitro diagnostic medical devices, whether or not in vacuum form, that are designated by the manufacturer to store samples taken from the human body for in vitro diagnostic testing. For example, disposable vacuum blood collection tubes. General laboratory equipment does not fall into the category of in vitro diagnostic medical devices unless, based on the characteristics of the product, the manufacturer specifically states that the device is an in vitro diagnostic medical device.
The manufacturer can only proceed if it has first determined that its product is an IVD, otherwise it will have to choose another corresponding method. At present, some domestic manufacturers have encountered trouble in this regard, for example, there is the production of drug abuse test kits, or athlete doping test kits, according to the definition of the IVDD directive, these products do not belong to the in vitro diagnostic medical equipment, and can not be according to the IVDD directive to apply for CE marking.
Step 2 Determine the classification of the IVD product and select the conformity assessment path
After the manufacturer has determined that its product is an IVD, the next step is to determine its classification and conformity assessment path. According to the requirements of the IVDD directive, IVD products can be divided into five categories, List A, List B, self-testing devices (except for blood glucose testing), other products, performance evaluation devices, and the conformity assessment path (that is, the path to obtain CE marking) for each category is different.
The third step to establish and maintain a quality management system
Manufacturers should establish a quality management system according to the requirements of the IVDD to comply with the requirements of the IVDD after determining the classification of the product and the route of conformity assessment. At present, in vitro diagnostic medical device manufacturers of the national category, generally in accordance with the requirements of the SFDA, the establishment of the GMP quality management system, but the GMP standard is not a coordinated standard of the IVDD, the IVDD coordinated standard for quality management system is ISO13485/8:1996 or ISO13485: 2003, therefore, the manufacturer should be in accordance with the requirements of ISO13485 Establish the quality management system, and then add some special requirements of IVDD, such as alert system, self-compliance declaration, etc.
For manufacturers who have already established a GMP system, the requirements of IVDD should be organically combined with the original familiar GMP or ISO13485 document structure, so as to establish a GMP/ISO13485/IVDD three-in-one unified quality management system to prepare for the audits of different organizations.
Step 4: Prepare CE technical documentation
The IVD Directive states in Chapter 9, Conformity Assessment Procedures, that the manufacturer should prepare technical documentation, and that this technical documentation should be kept for at least five years after the last batch of products has been produced, in order to be ready for inspection.
The IVD Directive describes very clearly in Appendix III what documents are included in the technical file. For manufacturers, all these documents are generated in the operation of the system, not specifically written, the manufacturer can be based on the requirements of the establishment of a list of technical documents, the collection of the required documents together, is the technical documentation.
CE technical documents have language requirements and are required to be in the official language of the country where the notified body is located. And, those that provide information about IVD products such as labels and instructions must be in the official language of the member state where they are sold.
Basic steps for applying for CE marking of in vitro diagnostic medical devices Step 5 Selection of an appropriate Notified Body
A Notified Body is a testing, auditing, and certification body designated by the competent authority of a member state of the European Union, which may carry out one or more of the conformity assessment procedures described in the Appendix to the IVDD. The Notified Body must be located in a Member State of the EU.
The selection of a Notified Body is one of the most critical issues facing manufacturers. In order to be able to work effectively a long and close relationship should be established with the Notified Body and the choice of the Notified Body should be made very carefully.
At present, there are a number of notified bodies in the domestic representative offices to carry out this aspect of the business, in general, manufacturers in the choice of notified bodies, should consider the following factors. First, the scope of IVDD certification authorized by the EU, the authorized conformity assessment procedures that can be carried out by the Notified Body, such as certain Notified Bodies do not have the qualification to certify List A products. Second, the local auditor resources of the notified body. If the notified body does not have auditors with IVDD audit qualification in China, it will definitely cause inconvenience in communication between the manufacturer and the notified body, and the cost will be multiplied. Third, the global reputation of the notified body. A globally recognized notified body is a guarantee of confidence for manufacturers and customers.
After the manufacturer chooses a suitable notified body, the notified body will audit the manufacturer's documents and conduct on-site audits, and decide whether to issue CE certificates based on the audit findings.
Sixth step: Obtaining CE certificate and registration
After obtaining the CE certificate from the Notified Body, the manufacturer can not sell the products to the EU member states based on this certificate, according to the provisions of Chapter 10 of the IVD Directive, the manufacturer has to go to the competent authorities of the member states (Competent Authorities, CA) to register, or entrust the EU representative to help the manufacturer to complete the registration. The manufacturer has to register with the competent authorities (CA) of the member states according to Chapter 10 of the IVD Directive, or ask the EU representative to help the manufacturer to complete the registration. If the manufacturer's products are sold in a member state of the European Union, it is necessary to register in that member state first. It is illegal for a manufacturer to sell products in an EU member state without registration after obtaining a CE certificate from a notified body.
Seventh step List A product batch inspection
In the IVD Directive Appendix IV.6 and Appendix VII.5 are stipulated in the List A product batch verification requirements (in addition to other types of products do not have this requirement), similar to China's SFDA batch batch inspection. IVD Directive manufacturer in each batch of products immediately after passing the manufacturing inspection, according to the prior and the announcement of the agency to send the samples to the announcement of the agency's agreement. The manufacturer of the IVD directive, immediately after each batch of product manufacturing inspection, according to the prior agreement with the announcement of the organization, the sample will be sent to the announcement of the organization for inspection, the announcement of the organization must be made in the specified time to respond, but may not be more than 30 days, to determine whether the batch of products can be marked with CE.
Step 8 Post-market surveillance and alert system
Post-market surveillance of in-vitro diagnostic medical devices, the same as medical devices, is included in the entire European Union's medical device alert system, the health authorities of the Member States are responsible for ensuring the quality of the products within the jurisdiction of the product, with the responsibility to notify, prohibit, and the competent authorities (competent authorities) also have the responsibility to ensure that the quality of products within the jurisdiction, with the responsibility to notify, prohibit. The competent authorities of each country (competent authorities) are also obliged to regularly assess the quality of the devices listed in the domestic market, especially the product items listed in Appendix II, no matter it is caused by the side effects of the device, product failure or shoddy manufacturing, once it directly or indirectly jeopardizes the life or health of the patient, the user, or other personnel, the competent authorities must order the manufacturer to take action immediately, such as recalling, informing, product quality issues. In addition to functionality, it also includes improper and incorrect labeling, labeling or instructions for use.
The competent authorities of the Member States will set up a European Databank under the EU system to ensure that Member States have effective access to information on the development of their products. In the case of in-vitro diagnostics and medical devices in general, the Databank will contain information on the registration data of the manufacturers and their products, and information on amendments, additions, holds, withdrawals or terminations of the product validation, Information on product failures, injuries or recalls. This will ensure that in vitro diagnostic medical devices throughout Europe are in the hands of the competent authorities of the Member States.
To this end, manufacturers are required to have a specific post-market surveillance procedure as well as an alert system, which needs to be validated by regular exercises in order to ensure that it can be activated at any time.