Contact
Contact Details
Telephone
Mail
Assistance Hours
Mon - Fri 9:00am - 8:00pm
Saturday, Sunday - CLOSED
Address
Central Address (Turkey)
Mavişehir Park Yaşam Ticaret Merkezi , 6523 Sokak 32/C; 35550 Karşıyaka / İZMİR
Istanbul Office (Turkey)
Velibaba Mah. Nene Hatun Cad. No:1/H D:41 Pendik / İstanbul
OMC Medical Limited Planet House (UK Partner Office)
North Heath Lane, Horsham, RH12 5QE, United Kingdom
Any Questions?
Frequent Asked Questions
1) When should I start preparing for the EU MDR?
Two years ago when the announcement of the new regulation was first made. Call us today at 05447772038 if you need help.2) Will these changes affect me?
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.3) Is my product obliged to comply with the EU MDR?
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, 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.