In April 2017, the EU adopted the Medical Device Regulation (MDR) to replace the existing Medical Devices Directive (93/42/EEC).The new regulation is intended to enhance patient safety by improving device quality. It also addresses industry changes that have occurred since the Medical Devices Directive was released in 1993.
The new EU MDR regulation has a “date of application” of May 26, 2020 when it becomes mandatory.
In this frame Qualimetrix has established an integrated package of services in order to meet the regulatory requirements.
- Regulatory strategy consultation
- Biocompatibility studies
- Chemical Characterization
- Toxicological risk assessment
- Cytotoxicity testing
- Irritation testing
- Sensitization testing