Recently, many EU medical device manufacturers are preparing to become a new in vitro diagnostic medical device (IVDR) regulation in the EU by the end of the year. The IVDR is a law proposed by the European Commission and endorsed by the European Parliament and Council, which will fundamentally change the mechanism of the CE mark and the way the EU regulates IVD devices.
New definition of in vitro diagnostic medical devices
So what is an in vitro diagnostic medical device (IVD) that is part of a medical device? A new in vitro diagnostic medical device (IVDR) regulation has been proposed to replace the current in vitro diagnostic medical device directive. The proposed regulations can be searched and read on the EU regulations index Eur-Lex. In this expanded regulation, the IVDR is defined as:
Means the sample that the manufacturer expects to be used for in vitro examination from the human body, including donated blood and tissue, reagents, reagent products, calibration items, control materials, kits, instruments, appliances, equipment, software, or used alone or in combination. The sole purpose or primary purpose of the system is to provide the following information:
· related to physiological or pathological conditions;
·About congenital anomalies;
· susceptibility to health conditions or diseases;
· determine safety and compatibility with those who may be treated;
· predict treatment effects or reactions;
· Identify or monitor treatment measures.
How IVDR will affect the classification of instruments
The IVDR will fundamentally change the mechanism of the CE mark. This mechanism will determine which IVDs can be labeled with the CE mark. Beginning with a new risk-based classification mechanism that replaces the classification of “general in vitro diagnostic reagents†with four new device categories: categories A, B, C, and D (corresponding to the lowest-level risk to the highest level, respectively) risk). The technical documentation for Class B to Class D products is subject to evaluation by the notified body. Technical documentation must include three types of clinical evidence:
1. Scientific validity: an analyte is associated with a clinical disease or physiological state
2. Analytical performance: The ability of IVD instruments to properly detect and measure analytes (LOD, LOQ, accuracy, accuracy, and reproducibility)
3. Clinical performance: The ability of the device to produce results that are relevant to the intended clinical use of the intended use and to the intended user (if applicable) based on the target population.
The new regulations emphasize exceptional supervision of the supply chain, including the announcement of surprise audits by key agencies and subcontractors. In addition, the new regulations regulate the regulatory role and requirements of importers, distributors and authorized representatives. An importer is any natural or legal person established within the European Union to place equipment from a third country on the EU market. A distributor is any natural or legal person that makes a device available to the market in addition to the manufacturer and importer of the supply chain. In some cases, the importer can also act as a distributor.
Manufacturers must insure their products for liability insurance; however, importers are responsible for verifying that the insurance is adequate or the importer must purchase additional insurance. In addition to the statutory manufacturer, an authorized representative must designate a person to be responsible for compliance within the organization. This person must be properly educated in the IVD field and have experience in the IVD field. Moreover, he must be responsible for technical documentation to ensure that compliance statements, performance assessments, and monitoring requirements are updated in a timely manner.
In addition, the new IVDR provides special provisions for companion diagnostics. One of the most important requirements is that the notified body must consult the competent authority after reviewing the technical documentation. We anticipate that specific guidelines for companion diagnostics will be released after the official publication of the IVDR.
Finally, IVDR is not limited to manufacturers of IVD kits that produce CE-marked labels. If you are a CLIA-certified laboratory in the United States and intend to sell self-built reagents in the EU, you will need to make some efforts because the same classification rules and compliance assessment paths are also applicable to laboratory self-built reagents (LDTs). ). At this point it is likely that a comprehensive quality system that meets international standards will be required and your design documentation/technical documentation will be reviewed by the Notified Body.
Conversion of IVDR regulations
The IVDR is a law proposed by the European Commission and approved by the European Parliament and Council. Once adopted, the regulations will be effective immediately in all member states. This means that the law will not be converted into the laws of individual member states.
The current draft regulations stipulate a five-year conversion period and full implementation of the regulation by 2021. During the conversion period, the manufacturer can choose to place the product on the market in accordance with current directives or to comply with new regulations. It is unclear whether there will be additional guidance on the market for self-guaranteed claims before the full implementation date, so it is still possible for manufacturers to continue to deliver their self-guaranteed statement type IVD products one day before implementation and maintain Sales in the market until the product expires.
According to the British Standards Institute (BSI), products that have obtained a certificate issued by a notified body during the conversion period can continue to be sold in the market within two years after the start of the implementation date, or within five years of the issuance of the certificate, with an earlier date quasi. It is unclear whether there will be additional restrictions on products of the type of self-assurance statement that requires a notified body certificate under the new regulations.
How to prepare
In view of the bleak regulatory situation in the future, it is recommended that manufacturers take the following measures in anticipation of the new regulations becoming law:
· Classification of IVD instruments according to new classification rules
· Perform gap analysis on existing technical documents
Identify important suppliers and key subcontractors to enhance existing supplier quality control
· Evaluate existing clinical evidence to prepare for further research
IVDR will fundamentally change the way the EU regulates IVD devices. Given that only 10-20% of diagnostic reagents currently need to be reviewed by the notified body, the new IVDR will regulate 80-90% of the IVDs that are self-certified under the current directive. Manufacturers are advised to plan ahead and be flexible to prepare for the new model.
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