The new Medical Devices framework consists of two Regulations:
- In Vitro Diagnostic Medical Device Regulation (IVDMDR) which will replace the current Council Directive 98/79 on In Vitro Diagnostic Medical Devices
- Medical Device Regulation (MDR) which will replace the following current Directives:
- Council Directive 93/42/EEC on Medical Devices
- Council Directive 90/385/EEC on Active Implantable Medical Devices
New rules for Medical Devices are being developed taking into account as the main objective, the safety.
The formal publication of these new Regulations is expected by the end of 2016, beginning of 2017 and the entry into force is expected by 2019/2020. However, it is time now to be prepared for the new regulatory requirements in order to be able to adapt the medical devices products that are currently marketed in Europe to the new rules.
These new Regulations have expanded the scope of the medical devices definition and now focus on disinfectants which will have impact on dual use products. When this new rules entry into force “Products specifically intended for the cleaning, disinfection or sterilisation of medical devices and devices for the purpose of control or support of conception shall be considered medical devices”.
Other improvements included in these Regulations are the designation of a person within the company responsible for regulatory compliance with required expertise in this area and also the assignation of a Unique Device Identification to facilitate traceability of devices.
For more information, please refer to EU Commission website and check the status of this New Regulatory framework.
Please contact us if you need our help to comply with these new Regulations.