MHRA Allows Devicemakers to Group Changes to Marketing Authorizations

Devicemakers seeking to amend a marketing authorization in the UK now can group a series of minor amendments in the same application, the Medicines and Healthcare products Regulatory Agency (MHRA) says in a guidance posted on its website this month. The changes should be related and meaningful to be reviewed simultaneously. However, applicants do not have to group them if there are advantages in making separate submissions for each of the nonconsequential changes.
International Medical Device Regulatory Monitor