The Countdown to EU MDR Compliance and the Role of Recruitment in 2019.

The start of November 2018 has marked the half-way point in the three-year transition period between the European Union's old directive for medical device regulation, and the new Medical Device Regulation (MDR). Not only is this affecting new medical device compliance for manufacturers, but also previously approved devices will need to be re-certified. Although Brexit is parallel during this journey towards new compliance, the EU represents 25% of the global medical device market and therefore affects all manufacturers, including the U.S.

The Countdown to EU MDR Compliance and the Role of Recruitment in 2019.

The Regulatory Affairs Professionals Society (RAPS) and KPMG recently put out a document that included thought-provoking statistics. It brought to light that 78% of medical device companies that responded to this survey do not have enough understanding of EU MDR and that 58% have no strategy in place to remediate gaps in their clinical data processes.

May 2020 is approaching, and so 2019 will be the crucial year of preparation for all involved in the Medical Device industry. A recent interview between ‘MDDI Online’ and Paul Brooks, the executive director of RAPS, revealed some key information.

Brooks stated that although the preparation will be headlined by the regulatory affairs department, all other sectors such as R&D, customer service, marketing, and quality are likely to be affected. Therefore, it is necessary for all departments to realise and prepare for the changes that must occur.
The survey also brings to light how imperative it is for the head regulatory/ quality professionals in these departments to be able to “translate” regulations into a language that can be understood by different audiences.

Over 80% of medical device manufacturers in the U.S. have less than 50 employees, adding much pressure to their work-load as this is a big responsibility for any employee to deal with. As a talent search/ recruitment company, we also believe it is our job to understand the new shape of MDR in 2020 in order to tailor service and find the most innovative and competent candidates for our clients.

Brookes also explains why “addressing QMS requirements with an all-inclusive perspective may be more efficient to avoid multiple revisions and duplications.” He states that when putting out devices to the Medical Device Single Audit Programme (MDSAP) markets e.g. the USA, addressing their QMS (quality management system) requirements is the most logical step for a manufacturer.   

In order to allow this transition to be as smooth as possible, the judgement of experts is needed to make sure the gaps in the process are identified and addressed, meaning a specific type of candidate is required. This is especially important as the requirements for clinical evidence will change and will need more data/ specific evaluations, which is worrying when the survey presented that 41% of MD companies have yet to evaluate the long-term maintenance needed for future compliance.

Despite this tough time for the MD industry, investments in innovative technology only show signs of growth. The International Trade Administration has stated that global medical device sales are predicted to increase by 6% in the upcoming 5 years. Uniform MDR will not stop the economic opportunities from being harnessed.

We at GXPeople want to be a part of the solution in 2019, and therefore will be keeping ourselves up-to-date with all the necessary notifications coming our way concerning MDR and will be sharing this knowledge with all our future candidates/ clients.

 

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