At least one person within an organization is required to ensure the regulatory compliance of the business (many business already have a quality or regulatory compliance or safety manager, so this isn’t a new regulation to many) (eumdr, 2017).
Products without an intended medical purpose will also be included in the MDR. This is specified in Annex XVI, which covers items intended for cosmetic purposes.
Within the new MDR, 16 Annexes are attached. Annex XVI in particular has raised concern with the manufacturers of cosmetic goods. This annex is focused on products without an intended medical purpose, and seeks to impose new guidelines that aim to protect the consumer.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
