M11 Med-Tech Forum: New Medical Device Regulations - what are the possible changes?
On Thursday 17th October 2013, Greer Deal (Director of Global Regulatory Services) presented at the second M11 Med-Tech Forum held in Harlow. She updated the group on the current status of the proposed changes to the EU Regulations which led to an open debate about the possible implications.
Key discussion points:
- The aim of the changes is to bring clarity to what is required along with some consistency across the EU.
- Clinical evidence to support claims on medical devices has always been required, the changes are a more formal mechanism with regards to how the evidence is presented to regulators.
- The term ‘clinical investigation’ used can be equated to ‘clinical trial’ in the biopharma world.
- The upshot is that regulation will be tougher than before (perhaps wisely so after failures such as PIP!), is likely to be adopted from 2015 – 2018, has introduced the term ‘sponsor’ to the clinical investigations and hence a liable party, aims to reduce the red tape burden on companies and will see a centralised adverse event reporting system
- The changes seem to be heading in one direction … towards a similar scheme as the US. This has potential to impact on the cost and timescales to get devices to market in Europe which in turn has implications for investors in the sector.
- There are some clinical centres and companies that already have excellent SOPs and approaches that will be well suited to adopting the new system, however there are many that are not. There could be an issue of competence gap in the shorter term.
- If there is a competency gap, perhaps lessons can be learned from the biopharma sector where such reporting is well established and it may provide an opportunity for training providers to create a centre of excellence (could that be this area taking a lead?).
- The longer term may see the development of a Pharmacovigilance Officer-style role in med tech companies when post-marketing approval reporting becomes required, although out-sourcing more likely for a while. It is already known, however, that there will be a requirement for a 'Responsible Person' for regulatory compliance within the company. How "within" is defined is yet to be confirmed but is a function which may well lend itself to be outsourced.
- It will remain to be seen if the med tech companies developing devices will pass these increased overhead costs on to their trial centres and supply chain, absorb the increase internally in light of more reward or increase the costs to the healthcare provider (unlikely to work in current cost containment environment).
- The degree of clinical investigation required will be proportionate to the perceived risk and benefit balance
- 22 October is the next key step when the Commission will vote on the proposal during a its plenary session.
The Med Tech Industry is going through significant change so it's important that companies are proactive in keeping up with these changes and don't adopt the all too frequent position of 'head in the sand'!
Author: Greer Deal, Director of Global Regulatory Services