Comments 0 comments
There are 27,000 medical device companies in Europe, employing 575,000 people, working on 500,000 products.
If you’re working for one of these companies, are you ready for 26th May 2020?
There are more than 500,000 life changing medical devices available on the market, ranging from plasters to total body scanners. Over the next few years the regulation of all of these devices is changing from the current Medical Devices Directive to new regulations – this is a big challenge for many of our clients.
The new MD Regulation 2017/745/EU comes into effect from 26th May 2020. The new regulations are a revision of the earlier directives so the impacts will not affect every company in the same way. Across the industry manufacturers of medical devices are carefully examining the lengthy document to assess the impact on their business.
Under the new regulation devices will still be classified under the same 4 classes as the current risk-based classification system, however some changes and additions have been introduced. Certain products will need to be reclassified, especially if they currently receive ‘special consideration’.
The classification of a medical device drives clinical stage and post-marketing requirements too. The new regulations have a ‘life-cycle’ approach to compliance and are more prescriptive than previous requirements. Some of the biggest changes relate to the technical documentation associated with Clinical Evaluation, Vigilance and Post Marketing Surveillance.
Obviously, Brexit is also a consideration for UK based Medical Devices companies when considering the impact of these new regulations, however the general consensus in the industry is that future UK regulation will mirror that of the EU.
Here at Meet the Medical Devices team have already seen an increase in the hiring of consultants to support with these regulation changes amongst our clients. What talent do you need in your team to support you with the change?
Please get in touch with the Medical Devices team to hear more about how they can support your hiring needs.
Source: MedTech Europe