The MedTech industry is going through a period of unprecedented change with the EU MDR implementation deadline in 2020 and IVDR in 2022. But how well really is the industry prepared for the changes ahead?
Are Competent Authorities ready? Do Notified Bodies have the resource and capacity? Do manufacturers have the tools and processes in place to ensure compliance? What are the key issues beyond compliance? Will the MDR and IVDR be fit for purpose? Will they facilitate innovation and ultimately, will they improve patient outcomes?
In February 2019, we asked MedTech professionals these questions and based on 291 responses created a State of the Industry Report that offered insights into the biggest challenges and how industry insiders are tackling them going into 2020.
The changes that the EU MDR/IVDR will have on the industry is one of the biggest concerns going into the new decade with much uncertainty. Indeed,when asked how innovation will be impacted, 58% of respondents thought it would have a 'Moderate' or 'Major' negative impact.
However, in contrast, respondents were more optimistic about how the new regulations would impact patient outcomes; 56% predicting a positive change.
With so much uncertainty around EU MDR, 32% of respondents thought the deadline would be extended beyond May 2020. The reasons were varied, as shown in the selected responses below.
Download the full MedTech State of the Industry Report here.
2020 should be a fascinating year for global pharma regulatory affairs. Market growth is shifting toward emerging markets in Asia, Latin America and elsewhere, where pharmaceutical sales are forecast to expand at double digit rates.
Meanwhile, updates on global eSubmissions, plans for implementing eCTD within National Procedures, and SPOR are now taking hold. For those in regulatory information management, there are numerous challenges ahead for publishing and operations professionals as they plan their regulatory strategy.
However, one thing in particular is likely to impact the field more than any other - especially in the UK and Europe; Brexit. As these graphics show, the majority of the 217 respondents to our February 2019 survey thought Brexit would have a negative impact on their daily work, for a huge variety of different reasons.
The pharmaceutical industry is facing an unprecedented level of disruption and the role of legal professionals in the industry is rapidly evolving to keep pace with the changing needs of the businesses they support. Rapidly advancing science is being counterbalanced with stricter regulations and challenges to the very core of how innovation is incentivised and funded. Legal professionals sit at the axis of these changes, increasingly tasked with being strategic partners and business enablers in the face of change.
On top of all this, Brexit is looming over 2020 for the UK and Europe. Respondents to our March 2019 survey were gloomy about the effects of Brexit on their business, with 66% expecting a 'Moderately' or 'Major' negative impact. As the selected responses show, the reasons were varied.
Download the full EU Pharma Law State of the Industry Report 2019.