On 25 May 2017 was announced that the transitional period of MDR will end on the 26 May 2020. The new Medical Device Regulation (MDR), also called the European Medical Device Regulation, should have came into force across Europe by the 26 May 2020. Due to the corona pandemic, the EU Commission has now decided to set 26 May 2021 as the amended date of implementation of the MDR.
Memmert has already successfully passed the extension of the MDD 93/42/EEC certificates.
Memmert successfully has passed the extension of the MDD 93/42/EEC certificates.
The existing EC certificate, directive 93/42/EEC was issued by the notified body and is now valid until May 2024 according to the transitional regulation (EU) 2017/745. The directive 93/42/EEC previously applied to medical device classes I, IIa and IIb.
New: Memmert is bringing medical devices of class I according to EU Directive 93/42/EEC into circulation until the regulation MDR (EU) 2017/745 comes into force. After the new regulation comes into force, Memmert will bring medical devices of class I into circulation according to MDR.
| Type | Intended Use as medical device | classification according to MDR |
|---|
| UNmplus/UFmplus | The appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm. | I |
| UNm/UFm/INm/ IFm | The appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm. | I |
| INmplus/IFmplus | The appliance may be used for temperature control of rinsing and infusion solutions and contrast agents. | I |
| IFbw | The appliance may be used for heating non-sterile covers and cloths. | I |
New: Memmert is bringing medical devices of class IIa and IIb into circulation according to MDD 93/42/EEC until 26 May 2024 according to the transitional provisions by the (EU) 2017/745 article 120 (2).
| Type | Intended use as medical device | Classification according to MDD |
|---|
| SNplus/SFplus | The product is intended for the sterilisation of medical devices with dry heat at atmospheric pressure. | IIb |
| SN/SF | The product is intended for the sterilisation of medical devices with dry heat at atmospheric pressure. | IIb |
| ICOmed | The appliance is intended for the creation and maintenance of constant environmental conditions for application in the field of in vitro fertilisation (IVF), especially for the incubation of oocytes, spermatozoa and zygotes in special culture dishes for IVF application as well as for gene expression and the biosynthesis of RNA and proteins. | IIa |
Note about using the software AtmoCONTROL in connection with medical devices
As a manufacturer, Memmert GmbH + Co. KG clearly labels its devices, which are medical devices in the sense of the European legislation. The AtmoCONTROL software is not a medical device. All MEMMERT medical devices can be used for their purpose without the software AtmoCONTROL. AtmoCONTROL is only intended for reading the data logging in conjunction with Memmert GmbH + CO. KG medical devices.
