SUMMARY BASED ON THE OGYEI NEWSLETTER REGARDING THE APPLICATION OF THE MDR REGULATION

On September 29, 2021, the National Institute of Pharmacy and Nutrition (hereinafter: “OGYEI” or “the Authority") published its newsletter (hereinafter: “Newsletter”) on Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter: “MDR” or “MDR Regulation”) in which the Authority has summarized the most frequently asked questions and technical details of rules for the transition to the MDR Regulation.

Below is our summary of the most important rules described in OGYEI Newsletter:

I. Legacy Device

In its Newsletter, OGYEI clarifies the definition of a legacy device. A legacy device is a medical device that has been placed on the market in accordance with the previous Directives (MDD (“Directive on Medical Devices”) and AIMD (“Directive on Active Implantable Medical Devices”) the certificate of which was issued by the notified body under the previous Directives continues its validity after the date the MDR becomes applicable. It is important for manufacturers to switch from using the MDD to the MDR after entry into force if there is a significant change to the medical device.

In the Authority's view, the following medical devices do not qualify as legacy devices based on the above definition:

• devices classified as “Risk Class I” (this does not include sterile, measuring function Class I devices that have a valid certificate according to the MDD);

• devices that have expired MDD certification and are now certified under the MDR; and,

• medical devices which already are marketed under the MDR (regardless of risk rating).

II. Liability of Manufacturers

OGYEI references the liability of manufacturers under the MDR Regulation. Under the MDR Regulation, it is the liability of manufacturers to classify medical devices according to product categories and risk classes.

Class I medical devices placed on the market under the MDD, which continue to be classified as Risk Class I under the MDR must comply with the conditions set out in the MDR Regulation from May 26, 2021.

OGYEI has uploaded detailed resources on its website to assist manufacturers with classification and registration.

III. Economic Operators Engaged in Distribution

The OGYEI Newsletter also covers the scope of issues concerning economic operators engaged in distribution - pursuant to Section 17 (3) and (5) of EüM Decree No. 4/2009 (III. 17) ‘an economic operator established in the territory of Hungary who markets a medical device, including medical devices that are medical aids in Hungary, or a nursing technical device must notify OGYEI for registration prior to the commencement of the distribution of the device.’

The newsletter provides detailed information on how to comply with the registration obligation for economic operators engaged in distribution, as well as a link to the application form and a guide for completion.

Also, the Newsletter draws attention to the following:

• the application form can be submitted separately for MDR and separately for IVDD and IVDR devices as well as medicinal caring technical devices;

• an economic operator marketing only a legacy device is not subject to the registration obligation unless the products are already marketed under the MDR; and,

• they cannot initiate registration without tools.

IV. Assistance in Classification, Risk Class I According to the MDR

The Newsletter published by OGYEI contains a detailed chart to assist manufacturers - according to which, on the one hand the products can be classified in Risk Class I, and on the other hand with examples illustrating the economic operators engaged in distribution. The products listed in the chart cannot be legacy devices as they are also classified in Risk Class I under the MDR rules.