Summary:
The UK company, a manufacturer of medical devices and equipment, has developed considerable expertise in the registration of medical devices with the relevant competent authorities. Based on this expertise, it is now offering to conclude outsourcing agreements with overseas medical device and equipment suppliers who are looking to appoint a “responsible person” to act on their behalf in the UK for the registration and regulatory compliance of their medical devices, now the UK has left the EU.
Description:
For over 25 years, the UK company has specialised in the design, manufacture and sale of high quality class I and class IIb non-implantable medical devices and medical equipment, supplying hospitals, clinics and universities worldwide. Its wide range of products includes medical lighting, operating tables, medical AV systems and control and power systems. The quality of its products and systems are assured through certification to the ISO 9001: 2015 and ISO 13485: 2016 quality management standards.
The company has grown rapidly in recent years, having moved to modern, purpose built premises in 2013. Its innovation and export performance has been recognised through multiple awards, including two Queen’s Awards (for innovation and international trade).
To date, conformity assessment and registration of medical devices in the UK has fallen within the scope of the EU Medical Devices Directive and there has been no need for EEA-based manufacturers to appoint an authorised representative in order to market their products here. However, now that the UK has left the Single Market, different arrangements apply and non-UK manufacturers are required to appoint a “UK responsible person” in order to export their products to this country.
Through experience of developing and registering its own products, the company’s technical staff has acquired both considerable expertise in this field and excellent contacts with the body responsible for the regulation and safety of medical devices in the UK, the Medicines & Healthcare products Regulatory Agency (MHRA).
It would therefore like to offer its services to act as “UK responsible person” for non-UK manufacturers of class I and class IIb (non-implantable) medical devices looking to export their products to this country, under an outsourcing agreement. These services would include assistance with the registration of their products with the MHRA, as well as acting as the UK contact point for any queries from the competent authorities or from healthcare professionals or users. Details of the precise package of services to be provided would be subject to negotiation with the partner.
Type (e.g. company, R&D institution…), field of industry and Role of Partner Sought:
Partners should be non-UK based suppliers of class I and class IIb non-implantable medical devices who wish to start, or continue, exporting their products to the UK.
The partner would be required to cooperate with the UK company, to provide all technical documentation required for registration and regulatory compliance and to respond in a timely manner to any requests for any additional information, as may be required by the UK competent authority (MHRA).
Stage of Development:
Already on the market
External code:
BOUK20210414002
