As the EU medical device regulation (MDR) deadline draws near, medical device manufacturers are increasingly under pressure to bring products into compliance and get submissions in front of regulators as soon as possible. With the MDR journey well underway, device manufacturers should have their gap analyses complete and roadmaps to the finish line thoroughly planned out. However, the industry is behind.
Where OEMs Are Now vs. Where They Should Be
Many manufacturers are running behind with their MDR implementation. Depending on how many products they need to test and who is carrying out testing, the process can take months or even years. Many small and mid-size companies are not ready due to limited resources, lack of regulatory knowledge, or simply not knowing where to start. Companies with a larger volume of products may be more at risk, especially if they haven't begun prioritizing products. However, those with fewer products and less ground to make up should already be working toward MDR compliance. If they're not, it's time to put the pedal to the metal.
Deciding on a Path Forward
OEMs have two options to complete preclinical device testing. The first is to conduct their own testing using in-house facilities and personnel. Companies that do not already have facilities up and running would have a lot to accomplish before testing can even begin; at this point, building an in-house lab may not be feasible. The alternative option is to outsource testing to a specialized lab or contract research organization (CRO). There are pros and cons to each approach, and selecting the best path forward comes down to several factors unique to the device manufacturer. Following are some criteria to help deter mine the best path forward.
The Pros of In-House Testing
There are a few advantages to...