Notified Bodies: eyes on the up-line


As discussed in our previous article, the current forecast for the medical device industry is stormy skies. A combination of the advent of the new EU Medical Device Regulations (EU MDR)[1] and a paucity of approved Notified Bodies means an increase in certification requirements but limited access to certifiers.

Without wanting to dampen spirits further, there is another grey cloud on the horizon to which manufacturers (and importers and distributors) need to be alive: supplier compliance.

It was recently reported that Spain’s sole Notified Body (NB 0318) was no longer intending to certify under EU MDR. Although it transpired that this might not necessarily be the case[2], it raised the question of who would be impacted by a development such as this?

Most immediately, any manufacturer currently supervised by that Notified Body would need to join the already bulging queue to be approved and monitored by BSI UK or TÜV SÜD. In addition, however, manufacturers down the supply chain, receiving components from other manufacturers or utilising sites supervised by that Notified Body, would need to take immediate action to find alternatives.

The basis for this is that regulatory compliance of suppliers, whether in regards to a component or an outsourced manufacturing stage, is an essential component of a quality management system.

Therefore, in addition to a manufacturer ensuring its own compliance with EU MDR, it must keep an eye on upstream suppliers. In our view, this means identifying all key actors in a supply chain and understanding their current and proposed regulatory activities – in particular, their EU MDR preparedness plan. This is also a timely reminder of the importance of well-drafted quality agreements, which give manufacturers options to access essential information, and take action if compliance issues in a supply chain become apparent.

Considered in this light, sector developments that might at first blush seem largely irrelevant (such as the possible withdrawal of the Spanish Notified Body) may in fact take on a new importance. Unfortunately, this only serves to further compound the increasing pressure on the medical device industry in the coming months.

[1] Regulation (EU) 2017/745.

[2] In fact, it appears that they are no longer accepting applications for CE marking under the MDD (93/42/EEC) and whether they intend to CE mark under the EU MDR remains unclear.