Consequences of terminating a subcontractor re continuity of supply


Happy Sunday all,

I am scoping a project to ascertain the feasibility of switching manufacturing facilities for a single-use sterile medical device with the aim of maintaining continuity of supply to our customers.

To date, the product has been exclusively assembled, packaged and sterilized by our subcontractor since 2012 whereas my employer, based in the UK, is the labelled manufacturer and CE mark owner. We hope to bring manufacture of the products in-house in December 2021.

The switch will mean very few changes to our CE/QMS certificate since we already manufacture in-house to that CE scope for similar products. However, we will need to requalify the facilities, V&V the product and inform our Notified Body of the changes which will take considerable time beyond D-day in December 2021.

In the meantime, we plan to purchase 6-12 months' worth of stock from our subcontractor to tide us over while in-house manufacture becomes operational.

My questions are:
1) How can I make sure that bulk-ordered stock can be legally exported to our Authorized Representative in Europe and sold to customers within the UK from January 2022 after our subcontract manufacturer contract is terminated?

2) Could we potentially be in breach of the MDD and our N.B.'s terms of service?

3) What sort of questions will the Notified Body be interested in asking us when we inform them of the change?

4) What sort of legal exposure could we be taking on by exporting a CE marked product without any signed Agreement in place with the subcontract manufacturer (i.e. lapsed agreement) and a 'patchy' Technical File while the V&V project is ongoing for the new in-house product?

5) How can we mitigate this risk?

6) If this is all indeed legal, what sort of time limit could there be by which point we'd have to scrap the bulk-ordered product before the expiry date?

7) Would our Declaration of Conformity and CE certificate be sufficient to claim compliance in the interim considering the CE certificate doesn't expire until 2023?

8) Are there any implication from the MDR and Brexit that could pull the rug out from under our feet?
Top Bottom