By Dr. Sunni Patel, medeuronet clinical scientist
With final discussions taking place within the Trilogue over the next several weeks and an agreement on the MDD overhaul expected in the New Year, medeuronet spoke to a key industry spokesperson on the process, John Brennan (picture left), Director of Regulations and Industrial Policy at EUCOMED.
EUCOMED, the European Trade Association for Medical Technology, encompasses work on various industry pressure points (regulatory, compliance, environment, market access, procurement, legal and clinical) helping companies to navigate the EU. John focuses on the rules and regulations surrounding getting devices onto the market and also assesses the industry environment – necessary to promote investment and business activity.
What is EUCOMED?
EUCOMED is a broad-based medical device trade association in the EU that represents all of the national trade associations (e.g., the ABHI in the UK) as well as major global players and manufacturers (e.g., J&J, Abbott, Medtronic).
EUCOMED represents all of these stakeholders (25,000 business in EU of which 95% are SME), which collectively represent €100 billion in the EU, in order to ensure their voices are heard at EU and national levels.
In respect to the recent MDD overhaul, within EUCOMED’s regulatory committees, member companies and national associations, such as the ABHI, analyze information from the original consultation of the Commission and put together industry positions and advocate these to policy makers.
BRIEF OVERVIEW OF THE MDD OVERHAUL
John notes that the industry is supportive of the overhaul of the legislation, particularly since many things have changed since the initial legislation was introduced in the 1990s. There is a need to update: as the medtech industry evolves, so must the legislation that governs it .
There had been several things that needed addressing for quite some time, and the PIP scandal was a further catalyst that brought the sector under critical review. The variation amongst notified bodies and vigilance issues in the member states (different reactions on the same issues from different member states at different time points of a product lifecycle) was creating a disharmony that had to be addressed.
The MDD overhaul is expected to help bring an overall clarity, especially on what and when action should be taken during the medical device approval process. This is not only helpful for patients to better safeguard their care, but also for the overall industry and may even help to improve trust in how it operates.
WILL THE MDD OVERHAUL ADVERSELY AFFECT THE APPROVAL AND INNOVATION PROCESS?
This, John notes, will depend on several factors. For instance, the legislation will need to be clear as to what requirements apply – the clinical evidence required alongside a solid clinical dossier for implantables and Class III devices is definite. However, the definition of clinical equivalence is still somewhat ‘up in the air’. The council will need to push a much clearer and more scientific definition of clinical data. Currently, it seems that this can only come from peer-review journals, which limits what data is presented (patient feedback, registry, real-life and observational could be dismissed). Companies will also have to pay careful attention to which devices they use to claim substantial equivalence – there will be a limitation as to how clinical equivalence will be used. These two factors create unnecessary difficulties, in particular for small companies, when generating data. John stresses that the validity (and definition) of clinical data is a scientific question that may be making companies unnecessarily carry out processes that aren’t even required by other worldwide agencies like the FDA.
It is important to take a step back, and ask – does this make scientific sense? Is there a risk that this legislation, if not clarified during the Trilogue, may require further investment for companies to submit sound clinical data in order to get their device approved for the EU market?
John is advocating for a scientific definition in order to make it much clearer and allow companies to seek the appropriate investment to generate sound clinical dossiers as part of the technical file. If the definitions of clinical data and equivalence are not clarified, it could artificially block or slow down much-needed innovation for no safety gain.
However, he does point out that the system will be a level playing field, i.e. the legislation will apply to everyone so that everyone is treated equally. Any advantage or disadvantage will apply to all. There will be greater focus on solid dossiers and solid clinical data, with a preference for clinical trials for class III and implantable devices which,, if managed and monitored efficiently, will ultimately help to promote innovation in the EU.
WHAT WOULD BE NEEDED TO FOSTER INNOVATION?
John expects three things:
- Clearer definitions
- Clear descriptions of how clinical dossiers will be put together
- What do the Notified Bodies assess and when?
This, he adds, will make things easier for manufacturers; they will know what they are committing to, what is expected of them and how they will interact with the Notified Bodies and Health Authorities to ensure approvals.
BRINGING PRAGMATISM TO THE TABLE
We asked John to bring a dose of reality as to what the legislation can ultimately mean and what we should be doing while discussions within the Trilogue take place.
John states that, quite simply, these revisions are a business issue, not just a regulatory issue, as they will fundamentally affect how to realize a product from conception to market place. For legacy products, where the ROI is marginal, it will affect a company’s product portfolio as it may not be worthwhile updating the clinical dossier for that product. This will obviously cause a shift in the medtech space and we may witness streamlining of portfolios among many companies.
From his interactions with manufacturers, John has found that around one third of businesses are already acting, another third are getting ready, while the remaining third risk being late in preparing. It is important to get planning, as legislation begins to get crystallised businesses can plan and invest on that. Transition times will be anything from 3 to 5 years on certain parts of the proposed legislation. Many will have to revisit their clinical dossiers, but will firstly have to make sure that it can be used to build off for any envisaged iterative innovation products.
Some practical points that all companies should envisage are to organise and prioritise product files, update technical documentation and labelling information so that it can be implemented readily.Click to tweet
Finally, it is vital not to underestimate the Notified Bodies. John advises that all manufacturers reach out to their national authority of their Notified Body to talk about what they expect of that body and if the authority expects the body to be fully involved within the new structure – and what the authorities’ preparedness is with the new legislation.
GETTING LOST IN THE SEA OF INFORMATION
There are a lot of myths out there and with the anticipation, it is quite easy to get overwhelmed with all of the information on forums and groups. John advises that while the legislation is still being discussed, it is better to be pragmatic on what will be expected of the industry and how timely companies are able to act and commit resources to implementing changes.
The commission proposal, parliament amendment and council text is available to review, and so the truth will be somewhere in the middle. All of these texts do exhibit some commonalties and agreements already (which make the Trilogue discussions somewhat easier), therefore from a risk management perspective, companies are already able to prepare on aspects of the legislation that will be expected to affect them in the near future.
We encourage active discussions with regulatory advisors, consultants and organisations as well as actively reviewing information released by associations like EUCOMED, who together with its members, will be developing a best practice guideline once the legislation is released , that will outline and disseminate an overview of the proposed changes to the industry.