MDSS News & Views

There are potential advantages of conducting business in the UK. The pressing question is: Can this also be achieved within the framework of the Medical Device Regulation (MDR)?

In instances where a virtual manufacturer lacks product design rights, both the UK Approved Body/EU Notified Body and the MHRA may consider a technical file from them, even if it contains redacted proprietary information. This is acceptable as long as the redacted details are not crucial for the UK Approved Body/EU Notified Body or the MHRA to assess the device's compliance with regulatory standards. It is advised to keep redactions to a minimum.

For virtual manufacturers holding redacted technical documentation, it is imperative to establish contractual arrangements, which ensures that the original equipment manufacturer (OEM) directly discloses all pertinent information to the UK Approved Body/EU Notified Body of the virtual manufacturer.

More detailed information can be found in the MHRA Guidance.

This is an additional solution to do business in the UK and should be carefully considered if the opportunity arises. Nonetheless, it is imperative to approach this as a strategic business discussion, as it allows your customer to market your products under their name as the virtual manufacturer. This move may introduce new business risks that need thorough evaluation.

The shortcomings of the past MDD did lead to the new rules in the EU with the MDR. Consequently, it makes the solution of virtual manufacturer impossible to apply without disclosing your secrets to your customer. The situation in the UK, however, presents a different scenario, as the UK still applies mostly MDD rules. However, even within the MDD framework, the EU had already taken a distinct stance on this issue, whereas the UK MHRA was more thoughtful of this matter.

Therefore, it is worth highlighting that the MHRA exhibits a pragmatic approach to this issue, aligning with their pragmatic approach to various other aspects.