A Key Consideration for MDR Compliance
Featured article by Mark Lanfear
It is critical to have the right talent. A knowledgeable and skilled workforce is a key piece of meeting unprecedented goals.
MDR compliance continues to be a complex and dynamic topic. In May of 2020, after the European Commission announced plans to delay compliance in light of disruptions from the coronavirus pandemic, and Parliament and Council greenlighted the postponement; many in the industry breathed a collective sigh of relief.
However, the one-year delay didn’t solve every challenge for the notified bodies designated for MDR work, and real trials continued for industry and regulators alike with new complexity, as the Medical Device Coordination Group (MDCG) permitted notified bodies to conduct remote audits during the coronavirus outbreak.
Medical device companies will need an executable global strategy based primarily on their staffing goals. This is necessary to reach the level of immediate action required to get the necessary resources allocated.
The EU Medical Device Regulations (MDR) go into effect on 26 May 2021, with the In Vitro Diagnostic Regulations (IVDR) set to follow on 26 May 2022. These regulations bring sweeping changes to the market clearance for medical devices within the European Union, and have far-reaching consequences for the life sciences industry.
MedTech and medical device companies are starting to partner with workforce solutions companies, because locating this in-demand expertise is something that may become bigger than they can handle in-house.
In a total talent solution, you can find the expertise you need by partnering with a company that already has a diverse pool of candidates to ramp up your staffing needs, and help you navigate any contingent labor management issues. This is including and not limited to:
- Managing suppliers
If outsourcing all aspects doesn't seem feasible, most workforce solutions companies can devise a solution specifically tailored to your needs. This can mean assistance with parts of the process, and most importantly, it's all scalable. You can ramp up to help with immediate needs to be compliant and scale back when you need to. There is an immediate greater focus and expansion of all services to address the current and future needs of not only the EU MDR, but all functionalities associated with the regulatory affairs, post-marketing surveillance, and product life-cycle enhancement. This means there will be a need for an increase of this niche workforce, and fast.