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Now. The MDR has applied since 26 May 2021; the transition periods have been extended, but the extensions depend on conditions and application deadlines. Call us today at (+90) 540 008 47 77 and we will assess the timeline that applies to your product.

If you market your device in the European Union (EU) under the MDD, note that there is no historical allocation of devices under the MDR. In addition, your device classification may have changed and may now require clinical assessment and renewal of the technical dossier.

The new EU Medical Device Regulation has broadened the scope of EU MDR applicability. Some products that were not previously recognized as medical devices are now covered by the medical device regulation. The newly added products include:

• 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, such as lasers and intense pulsed light equipment for skin resurfacing, tattooing, hair removal or other skin treatment.
• Equipment intended for brain stimulation that applies electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.

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 consultancy request form. Our team of EU MDR experts will help you plan your next steps.