Medical Devices Regulation (EU) 2017/745 (MDR)
ConvaTec EC and Declaration of Conformity Certificates
The ConvaTec group of companies (which includes Unomedical A/S and its affiliates) (collectively, “ConvaTec Group”) are committed to ensuring continuity of supply to our customers. Therefore, our transition to the MDR is being prioritised according to the risk classification of our products and expiry dates of their Medical Devices Directive 93/42/EEC (MDD) certificates.
You can access the IFUs here: IFU Section.
- All our Class I (non-sterile) products will transition no later than 26th May 2021 to MDR in accordance with the MDR requirements and the postponement of the application date.
- All our Class l (sterile) products will transition to the MDR during 2021. We will add the appropriate Declarations of Conformity for these products as and when they become available during 2021.
- All of our Class IIa, IIb and III products will transition to the MDR in accordance with the expiry of our current EC Certificates. We will add the appropriate Declarations of Conformity for these products as and when they become available.
- If you are a registered ConvaTec Distributor of our products, please click here to view available certificates and/or the approximate date of availability.
- MDD products already on the market can continue to be made available or put into service until 27 May 2025 (ref: MDR, Article 120(4)) or until the expiry of the related certificate, whichever comes first. The products can then continue to be used up until its expiry date. Therefore, it is acceptable for there to be MDD and MDR products on the market at the same time.