Regulatory affairs - December 2019 update

As I am sure you are aware, the MDR is now fast approaching and I am pleased to announce that Scala Surgical are rapidly moving towards meeting these new regulations. We expect to have most of our products fully compliant by the May 2024 date, however this will lead to some price, and delivery time changes.

For items that we have to order-in, we will provide you with a cost and lead time which reflects full compliance, and will communicate the changes to you so you can manage the new regulations in the best possible way.

Earlier this year we successfully completed our passivation process and we will incorporate this process for all marked products going forward. For stock items, we conduct a 100% quality check and we also aim to fully comply with the MDR. As part of this change, from January 1st 2020, we will brand all items and mark them for traceability. Each item will be individually bagged and labelled, and packaged in an eco-friendly way.

We aim for a 2-3 day turnaround of your orders depending on volumes and any specific requirements. As you can tell, there is a lot of work to do so we have introduced a 12pm cut-off time for orders to be dispatched the following day. For example, if you place your order on Monday by 12:01pm, your order will be processed as part of the next day’s orders, meaning you would receive your package by Thursday (subject to availability).

Over the past year, we have analysed our sales data and will become compliant for the most popular items as quickly as possible. We aim to become a manufacturer and would like to offer a virtual manufacturing agreement for those who would like it.

If you have a compliance requirement for a particular product which falls outside of our most popular items (this list will be sent out in due course), then please let us know so we can discuss forecasts and adjust our stocks accordingly, hopefully returning to a next day delivery service.

We are also in the process of introducing Sterilisation Containers to our product range which we will be showcasing at the IDSC exhibition next week in Hinckley.

If you have any questions, please feel free to get in touch with us on 0208 997 0077.

← Previous post