With the publication of the Medical Device and IVD Regulations earlier this year, as well as ongoing Brexit negotiations, this was definitely a timely event!
ABHI brought together some key speakers expert in their field from industry, Competent Authority and Notified Bodies who attempted to shed light on the implantation of the MDR over the next few years.
Psephos Biomedica will be bringing more detailed updates over the next few weeks and months, but here are some main highlights from the day.
Creating business opportunities in a time of change
Yvonne Puig, Head of Life Sciences and Healthcare (USA) for Norton Rose Fulbright opened the day with a clear call to view the present changes here in Europe (MDR / IVDR), the UK (Brexit) and the USA (Trump, et al) as opportunities for medical technology innovation, for creative business solutions, and for new market potential.
Some particular aspects she noted were that:
Compliance and quality should both underpin and drive future business, innovation & growth;
MDR compels all companies, but especially larger ones, to review their product portfolio, rationalise where necessary, and look to develop new efficiencies.
Key milestones ahead & the MHRA perspective
Gavia Taan, Snr Regulatory Policy Manager at the MHRA, presented a very clear overview of the coming years, the timeline for specific milestones that are ahead for regulators, Notified Bodies and manufacturers, and some insight into the actions Competent Authorities are taking to ease the transition process.
Some milestones of note:
26 Nov 17 – Notified Bodies can begin applying for notification under the MDR, however, the process is likely to take 6-12 months minimum (more later);
31 Dec 17 – the Medical Device Coordinating Group should be active by this date;
26 Mar 20 – EUDAMED should go live…, but may well not;
27 May 20 – MDR comes into force; no new devices may be placed on the market under the MDD.However, devices that have CE Mark under the MDD prior to this date may continue to be on the market until 16 May 2024 or until the relevant certification expires, whichever is sooner.
Gavia was joined later in the day by John Wilkinson, Director of Devices at the MHRA, and together they provided the conference with useful insights into current and future Competent Authority activities such as:
View from the Notified Bodies
The Notified Bodies community was represented by Martin Penver of LRQA, Suzanne Halliday of BSI, and Basil Akra of TÜV SÜD.
Each identified areas of concern, areas where guidance will be needed and areas of opportunity within the implantation process ahead.
1. Areas of concern
The most significant concern mentioned by Notified Bodies was that of appropriate resourcing being available. Of course, each NB wanted to promote that they have staffed up well in advance of need and that the main concern was for manufacturers but even so still seemed to ascent to the fact that there will definitely be challenges ahead.
They were also clear that they believed resourcing issues were going to be a potential significant concern for Competent Authorities and the European Commission over the next several years, as people with the appropriate training, qualifications and expertise are sought, found and introduced into the system.
2. Areas where guidance is needed
The Notified Bodies also highlighted the need for guidance on matters of transition (e.g. what changes, if any, can a manufacturer make to a device CE Marked under the MDD post-2020? What certification for “regulatory” QMS can be issued to a manufacturer post-2020?). In addition, there will need to be guidance on Classification and Conformity Assessment issues (e.g. for up-classified devices; for “exempt” devices; and for Class IIb implantable / Class IIb active to administer medicines).
3. Areas of opportunity
Realistically there seems to be few business opportunities for manufacturers over the next few years, but as with the first presentation of the day, the main “opportunity” that was suggested for industry was the need for companies to review their product portfolios and to remove devices that do not have sufficient evidence for CE Marking under the MDR and for which gathering that evidence would make them unprofitable. This seems to me to be less of an opportunity and more of an imperative!
Brexit and beyond
The overarching message around the topic of the UK leaving the European Union and the impact this will have on regulatory framework was very inconclusive. In effect, at this stage it is not known what will happen with the Competent Authority, Notified Bodies (that cover approx. 50% of all medical devices on the European market), manufacturers, Authorised Representatives (who account for over half the representation of overseas companies in Europe) and so on. That said, ABHI and MedTech Europe, as well as the MHRA and UK NBs (BSI, LRQA, SGS, Intertek & UL) are all lobbying for the retention of close ties and at very least a reciprocal relationship with the EU for medical devices and IVDs.
I am sure there will be a lot more to be said on this topic over the coming months and years.
Clinical Evaluations, Post Market Activities & Quality Management Systems
Regulatory strategic plans, clinical evaluation plans, post-market clinical follow-up plans, post-market surveillance plans, implementation of new vigilance reporting timelines, periodic safety update reports, summaries of safety and clinical evidence, more integration of risk management into the whole of the business, use of MEDDEV guidelines, absence of harmonised standards for the MDR, etc. Quite a list of areas for manufacturers to come to terms with over the next three years!
We will have more on all of these areas in the next series of Psephos blogs.
Person Responsible for Regulatory Compliance
As perhaps we are all aware by now, the MDR requires all manufacturers in the EU and all Authorised Representatives to have a “person responsible for regulatory compliance” (PRRC). Many have pointed out that this is not the same as the Qualified Person in the pharma world, and some discussion at the ABHI conference suggested that this wasn’t necessarily one person, but could be a function split over a few individuals, especially in a larger company.
This is an area that will definitely need clear guidance going forward with management teams, executive boards, and company directors needing to be very cognisant of potential liability issues if this role is not appropriately and adequately addressed. Again, more to follow….
CEO, Psephos Biomedica