MHRA released updates on the guidance of the legislation file for the in-vitro diagnostic (IVD) medical devices. There are 2 additional legal requirements applicable to the IVD manufacturers which are:
1. The Radioactive Material (Road Transport) (Great Britain) Regulations 2002
The Health and Safety Executives enforced the Regulations requires IVDs containing radioactive substances to abide with the requirements.
2. The Health and Safety at Work Act 1974
The Act enforces a responsibility to the person who designs, manufacturers, imports, or supplies any article for use-at-work, including IVDs, to ensure the safety and health risks of the article. There are requirements included for testing, examination, and dissemination of sufficient information regarding the use of the article.
On the other hand, the IVDs manufacturers are reminded that the UK Conformity Assessed (UKCA) marking is still permissible to use voluntarily through 30 June 2030. The manufacturers can apply the UKCA marking if certain that all of the requirements of UK MDR 2022 have been fulfilled. Any IVD medical devices bearing UKCA mark can be marketed in Great Britain, but not in the EU, EEA or Northern Ireland markets.
The affixation of the UKCA marking must be visible, legible and indelible on the device, instructions of use, and packaging. Besides, the UK approved body number and the name and address of the UK Responsible Person are also required to be affixed together with the UKCA marking.
The designated Responsible Person holds the marketing responsibility of the IVD in Great Britain. Apart from the registration and marketing duties, the Responsible Person would carry the responsibility to:
Sorting the technical documentation and conformity declaration based on the assessment procedure done by the manufacturers
Cooperate with MHRA on the requested documentations, samples, or preventives measures related to the IVDs products on the market
Informs the manufacturers on any health risks, complaints or reports from healthcare professionals, patients, or users related to the IVDs medical devices
Terminate the legal relationship with the manufacturer and inform MHRA or relevant approved body