Quality StandardsMercian Surgical operate a quality management system in compliance with ISO 13485:2016 - the world’s most widely recognised quality management system standard for medical devices. Allowing us to continually monitor and improve our company procedures across all operations.
We are legal Manufacturers of Class I, IIa and IIb medical devices and are currently certified to the following directive:
EU Medical Device Directive (MDD) 93/42/EEC (under notified body extension letter).
We are currently transitioning to the EU Medical Device Regulation (MDR) 2017/745 under the transitional provisions of Article 120 and are in the process of obtaining UKCA approval under UK MDR 2002.
Our medical devices are designed conform to applicable Essential Requirements and General Safety and Performance Requirements of the above regulations.
We are routinely audited by our respected notified and approved bodies to ensure compliance with applicable standards and regulatory requirements.
As required by Article 11 of EU MDR 2017/745, we have appointed an EU Authorised Representative at the following address within the European Union: Advena Ltd, Tower Business Centre, 2nd Flr. Tower Street Swatar, BKR 4013 Malta.
We are registered and regulated by the UK Competent Authority, The Medicines and Healthcare Products Regulatory Agency (MHRA) as a legal manufacturer of medical devices.
Copies of our current certificates are available to download below.
