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Update from BIVDA’s Regulatory Affairs Manager on current priorities

By October 29, 2021No Comments

As many of you are aware, I had the pleasure of joining BIVDA on the 25 of October as Regulatory Affairs Manager. I’m now coming to the end of my first week in the role, and I’m so thrilled already to be part of such an amazing team.

This week has involved bringing me up to speed with ongoing work, including plans for how my joining can add to the team and the needs of the members. Prior to joining BIVDA, I worked at the Medicines and Healthcare products Regulatory Agency. My time there spanned various roles, including post-market surveillance, policy and regulatory positions, and a focus on market surveillance for medical devices and IVDs.

As my title suggests, my primary role at BIVDA is expanding our work in the regulatory sphere. This will likely involve feeding into the relevant working groups, informing you all of any key updates within the field, and generally being a point of contact as and when needed. My aim is to shine a bit of a limelight on the regulations around IVDs and increase the work BIVDA does in this field. This doesn’t necessary only relate to direct IVD legislation; I’m already getting stuck into all the other areas which touch IVDs indirectly, such as environmental considerations, sustainability and chemicals.

My first major piece of work will be BIVDA’s contribution to the consultation on the future regulation of medical devices in the United Kingdom being undertaken by MHRA. This is a project BIVDA will be inputting heavily on considering it will have huge consequences for IVDs, meaning I will need support from members to know exactly what feedback you would like to be submitted. I am still in the process of identifying the best way to take this forward, but it would be helpful if you could provide me with any feedback you have provided so far, or send it to me as and when you supply it. Although BIVDA intends to provide feedback directly on behalf of members as a Sector voice, I still very much encourage each of you to submit your own feedback in parallel. The more contributions received, the better likelihood we have of steering key changes in the IVD sector. The consultation closes on the 25 of November.

There are also a number of ongoing projects in relation to the IVDR due to become fully applicable in May 2022. The EU Commission has published a proposal for a staggered delay of this implementation date, and I will be keeping up to date with any changes (or decisions) made on this. In the meantime, we will be pushing towards the May application date until told otherwise. It is quite a busy time in the IVD Regulatory space!

I am very much hoping to meet most of you in the coming months at various events, but please feel free to reach out for a conversation before then. Ultimately, BIVDA is a member-driven association, so I need your input to know how my role can help you as a member; I would be keen to hear your feedback on what you would like me to bring to BIVDA.

Michael

About Michael