News

Termination of the Medical Device Directive - Introduction of the Medical Device Regulation

On 26 May 2020, the transitional period of MDR that started on 05 May 2017 will end. That is when the new Medical Device Regulation (MDR), also called the European Medical Device Regulation, will go into effect across Europe.

What does this mean for medical devices from Memmert?

Memmert successfully passed the extension of the MDD (Medical Device Directive) 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 into circulation starting 26 May 2020 according to MDR ((EU) 2017/745).

TypeIntended Use as medical deviceclassification according to  MDR
UNmplus/UFmplusThe appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm.I
UNm/UFm/INm/ IFmThe appliance may be used for heating fango, silicate and APS packs for physical therapy and keeping them warm.I
INmplus/IFmplusThe 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).

TypeIntended use as medical deviceClassification according to MDD
SNplus/SFplusThe product is intended for the sterilisation of medical devices with dry heat at atmospheric pressure.IIb
SN/SFThe product is intended for the sterilisation of medical devices with dry heat at atmospheric pressure.IIb
ICOmedThe 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 and data logging in conjunction with Memmert GmbH + CO. KG medical devices.