A Formal Announcement towards European Medical Devices Regulation 2017/745.

FSP Group, Mönchengladbach, 04.05.2021 - To prevent shortages or delays in getting key medical devices on the market, European Union Parliament postponed the application of European Medical Devices Regulation 2017/745 (MDR) for one year. On 26 May, 2021, the new MDR is scheduled to replace two Directives: Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD 90/385 EEC). Here FSP Power Solution formally announces our action towards the new regulation: 

Following the new MDR, the CE marking on FSP / Protek Power medical power supplies that declared against MDD would be cancelled because of three reasons: 

1. MDR cannot be applied to an independently produced standard power equipment.
2. As a Medical-based power supply is not designated for clear medical purposes, it is not classified as a medical device or an accessory in the new regulation.
3. A Unique Device Identification (UDI) number is a must-to apply code for a medical device. Being a non-medical devices product, a medical power supply would not be assigned for a UDI number. 

Even though the entire series of FSP / Protek medical power supplies is qualified for a variety of medical applications, FSP Group is not in a position to declare the products of meeting MDR standard.

As per European Union’s CE marking page states, “Not all products must have CE marking. It is compulsory only for most of the products covered by the New Approach Directives. It is forbidden to affix CE marking to other products.” (https://ec.europa.eu/growth/single-market/ce-marking_en) 

A medical grade power supply is a part of a medical apparatus which could only be considered as an accessory without medical function. Neither CE marking, nor Declaration of Conformity is required. Therefore, the CE logo on FSP / Protek Power medical power supplies that declared against MDD would therefore be removed once the new regulation comes into force.