Detail of outcome
There were no strong views on the transfer of responsibility for the Certificates of Free Sale for medical devices scheme from DH to the Medicines and Healthcare products Regulatory Agency (MHRA).
There was general agreement that the change would bring the UK into alignment with the rest of Europe. However, a number of specific points were raised by respondents which DH and MHRA will ensure are taken into account when the transfer takes place.
The initial proposed effective transfer date was 1 April 2014. This is now unlikely to happen before the end of 2014, mainly because MHRA needs to:
- build a new IT system to run an effective scheme
- set out their proposed fee regime in a further full public consultation later in 2014
The delay will have no adverse consequences for the businesses that use the scheme.
14 responses were received and have been shared with the MHRA. As part of the consultation a letter was sent to the 4 main trade bodies representing the medical technology sector and to a number of companies who regularly apply for certificates but are not members of those bodies.
We are seeking views on the proposal that the Medicines and Healthcare products Regulatory Agency (MHRA) should take on the operation of the Certificates of Free Sale (CFS) for medical devices scheme. It is proposed that the responsibility should transfer from the Department of Health on 1 April 2014.
CFS are issued to UK based medical device companies to support UK industry and jobs, and to help export products to countries outside the EU. The proposed change to the scheme has implications for the companies that use it, so we are keen to get their reactions and those of relevant trade associations.