The Medical Devices Regulation (MDR) will replace the current EU Medical Devices Directive (93/42/EEC) and the EU Directive on active implantable medical devices (90/385/EEC).
2. When will MDR be implemented?
The MDR came into force on May 25, 2017.
3.Under the MDR regulations, if a company changes its name but there is no change in the entity, does it need to apply for a separate assessment?
This situation is not specifically regulated by the MDR, and it is necessary to refer to the official guidance issued subsequently (especially regarding EUDAMED/SRN).
4. What products are covered by MDR?
The MDR includes all products covered by MDD and AIMDD. The new regulation expands the scope of application to cover some products for non-medical use, such as contacts, facial fillers or injections, liposuction for weight loss, skin improvement and cosmetic products. For details, please refer to Annex XVI in the MDR.
5. Has there been any change in the classification of medical device products in the EU?
There are some changes in the MDR classification rules for products with a wider range of applications than MDD and AIMDD. For details, please refer to Annex VIII of MDR.
6. Do Class I (sterile or measuring) devices require the intervention of a notified body to obtain a CE marking certificate for medical devices?
Yes, but the scope of review by a Notified Body is limited to the sterility and metrology aspects of such devices. However, self-declaration can be used in MDR for Class I (non-measuring, non-sterile, non-reusable products).
7. Is the 5-year renewal audit for Class III products audited by the European Commission or by the issuing notified body?
If there is no substantial change in the product, the 5-year license renewal audit does not need to be reviewed by the European Commission. If there is a substantial change in the product, the intervention of the European Commission is required.
8. Does the UDI apply to both individual product packaging and packaging for multiple products?
In the case of individually packaged products, the UDI is required on each individual product package. for multiple product packages, (e.g., a box of surgical gloves), only the outer package is required to display the UDI. see Article 27 and Annex VI of the regulation for details.
9. Are the new UDI requirements consistent with the current U.S. FDA's UDI requirements?
There are some differences between the MDR and FDA UDI requirements. However, there are also many similarities. See Annex VI for UDI requirements.
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