Why It’s All Gone Quiet On EU Medical Device Regs Changes

In short

For those of us with an inbuilt action-orientation, it seems like the wheels of European legislature turn extremely slowly. That’s because they do. So we thought we’d remind our readers where we’re up to and what might happen next.


The Medical Device Directive(MDD) that governs the way products are brought to market and controlled in market, dates back to 1993 and has remained fundamentally the same since then. Responsibility for the existence and implementation of the directive ultimately lies with the European Parliament, and this august body set up a European commission which accepted proposals for a series of revisions to the MDD in September 2012.

There now commences a seemingly interminable delay before implementation as the proposal passes through the required legislative pathway until it becomes law. That is variously estimated as being likely to happen in late 2014/early 2015. While that may seem like a long time, consider the lobbying, fine-tuning, i-dotting and t-crossing that needs to be made to happen and you could be forgiven for pitying those responsible for making it happen. And indeed when you look at some of the structural changes being demanded, this is big stuff.

Just to remind you of what the changes are (from European commission website). The Commission proposes important changes regarding various aspects relevant for the life-cycle of medical devices, such as the scope of the legislation, the pre-market assessment of devices, their control once on the market, the transparency of data concerning marketed devices and the management of the regulatory system by the authorities.


  1. Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests.
  2. Stronger supervision of independent conformity assessment bodies (so called ‘notified bodies’) by national authorities.
  3. More powers for notified bodies vis-à-vis the manufacturers, to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites.
  4. Clearer rights and responsibilities for manufacturers, authorised representatives, importers and distributors, including in the case of diagnostic services and internet sales.
  5. Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market.
  6. Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls).
  7. Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices.
  8. Adaptation of the general health and safety requirements, including labelling provisions, to the technological and scientific progress.
  9. Introduction of classification rules that divide the broad range of in vitro diagnostic medical devices into four different risk classes as it already exists for other medical devices.
  10. Creation of a Medical Device Coordination Group composed of members representing national competent authorities in the field of medical devices to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support.

The big ticket items are clearly the reform of the notified bodies (2), the database (5), new traceability rules (6), and new clinical investigation rules (7).  This last one is the area that has probably provoked the strongest opposition, from industry at least, as it’s the one that leads us down a road that is starting to look like higher risk devices will need supportive data akin to that required for US FDA PMA approval. It’s an uphill battle to convince the public (and their political representatives) that devices used on them shouldn’t have to undergo the utmost level of scrutiny. yet there is little evidence that these “higher risk” products that get to market in the United States have a lower level of in-market problems than in Europe.

Spinning that another way, the benefits of getting new technologies to market so much earlier in the EU don’t seem to come with a price tag of underperformance. This is European medtech industry body Eucomed’s position, it having set up a campaign based on “don’t lose the 3” (years earlier to market in EU).

So what happens next is that you’ll hear periodic announcements right up until the day this thing becomes law in whatever shape or form it finally ends up.