Are you prepared for MDR?
With the introduction of new Medical Device Regulations (MDR), Medical Device companies are having to perform audits on their products and internal processes. We spoke to Real Staffing’s dedicated Medical Device team to find out how some companies are adapting to the changes.
An overview of MDR
By 2020, all medical device companies must comply with new medical device regulations. Real Staffing’s Medical Device team have recently been supporting clients with this transition from the previous Medical Devices Directive. MDR is set to provide better transparency and tighten regulations around clinical investigations. This is to provide safer products, and to develop cooperation of product monitoring across European manufacturing.
How MDR can impact the Medical Device industry
One of the newest ways MDR will impact the industry is through the regulation of some cosmetic devices like contact lenses, epilation lasers, and liposuction equipment. Even the latest version of the Apple iWatch has now been classified as a Class 2 Medical Device.
Failure to meet the new regulations can halt or cancel an entire project’s manufacturing process, and could even lead to potential fines from stakeholders. Companies cannot risk the potential profit loss and the expenditure needed to hire in new professionals because of an MDR failure. Due to the innovative nature of the industry, these delays could affect the success of a product when it enters the market. Products that are MDR compliant will have the advantage of less competition when they enter the market, due to competing products still working under the MDD certification.
Some of the regulators involved in the creation of MDR also work for large medical device companies. This has provided opportunities for smaller companies who cannot afford to make their products MDR-compliant, to be acquired by larger companies. With a larger company acquiring a new SME business, it allows the projects to continue. However, some experts feel that SMEs are the leaders of innovation, and with the involvement of more stakeholders within a larger organisation, it could slow down the innovation process due to additional internal approvals.
How Real Staffing is helping businesses adjust to MDR
With the potential risks that come from ill preparation around MDR, our medical device team are on hand to assist businesses on a consultancy basis. Real Staffing’s Medical Device specialist Nathan Puxty says, ‘Through the transition of MDR I’ve developed a close connection with candidates who have undergone training courses to become MDR compliant, this has helped build confidence and security with my clients, as I know that I can help them through the MDR process on every step of their journey. I have even recently placed an official MDR consultant to help lead them through the transition’.
John Lennon, of Real Staffing’s Medical Device team explains how he has connected with a specialist network of MDR consultants, ‘I have recently placed a consultant who is providing a short term gap analysis on MDR. My client was looking for a consultant that can indicate future requirements in order for them to be compliant’.
With our network of MDR-ready professionals, we have developed their own understanding, and can offer industry insights to clients who require more clarity on how MDR has been introduced.
If you’re in need of more information about complying with the new MDR regulations, or are in need of a specialist to help lead your team through the process, get in touch with the Medical Device team at Real Staffing.