In vitro Diagnostics Regulation IVDR
The Regulation was adopted by the European Council on 07.03.17. On 5 May 2017, the In Vitro Diagnostics Directive was published in the Official Journal of the EU. It entered into force on 26 May 2017 and has a transition period until 26 May 2022.
Who does the IVDR affect?
The IVDR affects all economic operators in the complete supply chain. The manufacturers provide the articles with UDI codes. Wholesalers, importers and distributors must check and record the articles. This creates clear traceability.
At what point are you a manufacturer?
A manufacturer can be any natural and legal person. This person manufactures or develops products. One is also a manufacturer if one has products manufactured and then puts one´s own name on them and markets them.
What is the In Vitro Diagnostics Directive?
The new directive poses a major challenge for manufacturers of in vitro diagnostics. Products must be given a unique device identification (UDI) number. This should make traceability easier, as products can and, according to guidelines, must be tracked throughout the supply chain, depending on the participant in the supply chain. In the event of an in vitro diagnostics (IVD) recall, the recall can be carried out quickly and safely.
In addition, the new directive introduces a new classification system, which is divided into 4 classes (risk classes A to D). In class A the products with low risk are classified and in D products with high risk for patients and the public.
As another new item, manufacturers must appoint at least one qualified person at their facility who is responsible for ensuring compliance with the new requirements.
In vitro diagnostic (IVD) is a term for medical devices used for medical laboratory testing of specimens derived from the human body.
The sole or primary purpose of IVD is to provide information on one or more of the following
(a) about physiological or pathological processes or conditions,
b) about congenital physical or mental impairments,
(c) about the predisposition to a particular health condition or disease,
(d) to establish safety and tolerability among potential recipients,
(e) about the likely effect of a treatment or the likely reactions to it; or
(f) to establish or monitor therapeutic measures.
EU Regulation 2017/746Healthcare devices at COSYS
Compliance with MDR and IVDR starts with the right hardware. Only professional barcode scanning hardware ensures compliance with EU regulations and allows complete traceability of medical devices and in vitro diagnostics along the supply chain. By scanning barcodes and data matrix codes, traceability is made possible. Therefore, MDE devices and handheld scanners are of high importance for pharmaceutical companies to meet the requirements of the EU.
With COSYS you have a competent partner who can advise you in detail about the right hardware. In addition to classic MDE devices for harsh working conditions, we also offer you MDE hardware specially suited for the healthcare sector, so that you can meet EU requirements.
Our experts will be happy to take the time to find a perfect hardware solution for you!
In addition to hardware solutions, the camera can also be used to capture barcodes and data matrix codes. The COSYS Performance Scanning software captures codes at lightning speed, and the smartphone camera can be used to scan the codes.
Turn your smartphones, tablets and wearables into true enterprise-class barcode scanners that can be used in any business environment with COSYS. Image recognition algorithms and the high processing power of smartphones allow codes to be scanned at breathtaking speed and accuracy - significantly faster and better than ordinary barcode scanners.
