AUGUST 26, 2022 IS THE DEADLINE FOR THE NOR-REGISTRATION OF ECONOMIC OPERATORS CARRYING OUT DISTRIBUTION ACTIVITY
On April 5, 2017, the European Parliament and the Council adopted Regulations No. 2017/745 on medical devices (“MDR”) and No. 2017/246 on in vitro diagnostic medical devices (“IVDR”). Article 30 of the MDR and the IVDR allows Member States to maintain or introduce national provisions concerning the registration of distributors of devices which have been made available in their territory.
In Hungary, the local registration obligation for economic operators which have their seat in Hungary and distribute medical devices made available on the market under the MDR, was introduced by Section 17(3) and (5) of Decree No. 4/2009 (III. 17) of the Ministry of Health on medical devices and by Section 7/A(2) of Decree No. 8/2003 (III. 13) of the Ministry of Health on in vitro diagnostic medical devices. Under the current legislation in force, economic operators carrying out distribution activities must register with the National Register of Medical Devices (“NOR”) both their own devices and the devices that they distribute in Hungary.
What is Distribution?
Pursuant to the interpretative provisions of the MDR and the IVDR, making a medical device available on the market means any supply of the device, consumption or use on the EU market in the course of a commercial activity, both in return of payment or free of charge. A distributor is any natural or legal person in the supply chain, other than the manufacturer or the importer, which make the device available on the market, up until the point of transferring them to use.
Based on the definitions the main focus is on the activity, which means that the registration obligation is not limited to distributors, although registration is colloquially referred to as ‘distributor registration’. For example, in many cases, economic operators engaged in import activities are also engaged in distribution activities and are therefore subject to the registration obligation.
We must emphasize that the registration obligation only applies to medical devices placed on the market under the MDR, therefore the so-called legacy devices, which were placed on the market under the prior legislation, the Medical Device Directive do not need to be registered.
We collected some examples of who may qualify as an economic operator engaged in distribution:
- pharmacy; and,
- importer (in certain cases).
What is the Registration Deadline?
Economic operators having a registered seat in Hungary must comply with the registration obligation by August 26, 2022, pursuant to Decree No. 8/2022 (II. 18.) of EMMI amending Decree No. 4/2009 (III. 17.) of the Minister of Health on medical devices.
On its website, the National Institute of Pharmacy and Nutrition provides guidance to distributors on the registration procedure to facilitate the registration of the economic operators and the medical devices they distribute in Hungary.
If you have any further questions about the NOR registration, please do not hesitate to contact us.