1) When should I start preparing for the EU MDR?

2) Will these changes affect me?

3) Is my product obliged to comply with the EU MDR?

• Contact lenses or other substances intended to be inserted into or on the eye.
• Products intended to be inserted, in whole or in part, into the human body by surgically invasive means for the purpose of altering the anatomy or fixation of body parts, except for tattoo products and piercings.
• Substances, combinations of substances or items intended for use for filling the face or other dermal or mucous membranes by subcutaneous, submucosal or intradermal injection or other introduction, except for tattooing.
• Equipment intended for use to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
• Equipment that emits high-intensity electromagnetic radiation (e.g. infrared, visible light and ultraviolet) intended for use on the human body, including monochromatic and broad spectrum, such as coherent and incoherent sources, lasers and intense pulsed light equipment for skin resurfacing, tattooing or hair removal or other skin treatment.
• The skull to alter neuronal activity in the brain.

4) What is the first step I should take now?

We know that the EU is a huge market for any medical device manufacturer and losing this revenue will have a negative impact on your business. We recommend you start by conducting a gap analysis of your current quality system and documentation. Contact us now using the form below. Our team of EU MDR experts will help you plan your next steps.