Market orthopaedic and dental medical devices in the EU and UK with certification from SGS.
To access European and UK markets, orthopaedic and dental device manufacturers must be approved by the relevant regulatory body. For the EU, manufacturers must follow the Medical Device Regulation (MDR 2017/745) and be certified by a Notified Body (NB), like SGS, to use the CE Mark.
The UK requires adherence to similar regulations and certification by an Approved Body to receive the UK Conformity Assessed (UKCA) mark. We can also help you to achieve your UKCA mark.
What are orthopaedic devices?
An orthopaedic device covers temporary and permanent implants, accessories, spinal implants and instrumentation. An implant either corrects or replaces joint, bone or cartilage, and can be metallic, plastic or made from animal or human tissue.
What are dental devices?
A dental device is an implant, or a component of an implant, used for dental procedures. Like an orthopaedic device, a dental device must be approved by the relevant NB to be placed on EU or UK markets.
What about contract manufacturers?
Contract manufacturers play an important role in medical devices. Manufacturers can open new markets with a certified quality management system (QMS).
We have the professional orthopaedic expertise, availability and commitment to help you obtain certification. We focus on you and have a unique perspective to assist those new to the European and UK regulations.
SGS recommends a Needs Analysis to review your certification strategy and helps you understand the certification journey and possible timelines. The first step in a successful journey starts with training.
We frequently hold public training courses to help you understand the requirements to access various markets, including developing acceptable technical files and correctly implementing the requirements.
In addition, we have ISO 13485 (medical devices quality management system (QMS)) training and our assessors can certify a QMS against the standard and ensure an effective system is in place.