MDCG 2022-4: New Notified Body Audit Guidance Document for Legacy Medical Devices
21 February 2022
Northern Ireland Medical Device Requirements
1 March 2022The deadline to appoint a Swiss Authorized Representative (AR) for mid-risk devices is nearly here.
Manufacturers of Class IIb non-implantable and Class IIa devices must appoint their Swiss AR by 31 March 2022.
The Swiss AR must submit a mandate to Swissmedic to verify the appointment. From that appointment date, the manufacturer must identify the Swiss AR on its labeling. Swissmedic has released a ‘CH-REP’ symbol for this purpose.
If you have devices in this category and are actively placing them onto the Swiss market, you must comply with the above requirement.
The deadline for Class I devices and Systems / Procedure Packs is 31 July 2022.
