BDIA seminar reveals dental MDR priorities
26 October 2018
On 25th October we welcomed members to a specially tailored seminar on Medical Device Regulation implementation from the perspective of the dental industry. Presentations from the ABHI, MHRA, BSI and TUV SUD highlighted the particular challenges and priorities facing our industry as it moves further along the MDR transition process.
The Notified Bodies present stressed the need for companies to engage with them as a matter of urgency in order to discuss transition requirements. Particular priorities that emerged included clinical data and post-market surveillance, especially in light of the much higher bar for demonstrating equivalence, as well as NB involvement for Class I reusables and the potential for significant upclassification of devices featuring medicinal products – such as pastes and restorative materials containing or releasing fluoride.
On a range of issues, from preparation of clinical data to MDD certification during the grace period, the message was clear: leaving preparations until the last minute is not an option and companies need to be proactive in working with their NBs to ensure that they can achieve certification in time.
