Medical device regulation (MDR) certification services
Medical device regulation (MDR) certification services
We review your medical device to ensure conformity with the relevant regulations by offering a range of product review services to bring your device to the market.
The EU MDR 2017/745 came into effect in May 2021. All medical devices certified under the previous Medical Device Directive (MDD) must be certified to the new requirements to ensure that they can continue to be sold in the European market. Our MDR certification services provide a one-stop solution for all your medical device certification needs.
We can help you
We can help you
(1) Understand the requirements through our training courses (2) Confirm your products meet MDR requirements (3) Acquire up-to-date MDR certification (4) Gain the CE mark for your medical devices to ensure EU market access
We can ensure that medical devices certified under the MDD transition smoothly to the latest MDR certification requirements, which now cover following.
(1) Broader scope and up-classification rules (2) Tougher clinical evaluation (3) Improved EUDAMED database to enhance traceability and transparency (4)New unique device identifiers (UDIs) (5) Stronger post-market surveillance (7) Reinforced regulatory requirements (8) Regulatory compliance responsibilities at the organization level (9) Extended scope on products with no medical purpose but that are equivalent to devices with a medical purpose
MDR certification process
MDR certification process
The requirements imposed by EU MDR compliance are complex and apply to multiple device types, including Class IIa, Class IIb (implantable and non-implantable), and Class III devices. We provide the unrivaled expertise in MDR requirements you need for a smooth certification process. Certification can take between 12 and 18 months, and in some cases longer.