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Dramatic changes expected into medical device regulations

A slew of updates to existing medical device and diagnostics (MD & D) regulations is on the cards. Medical device and diagnostics is a field that keeps changing every now and then. But what is different this time is that the industry is up against a series of updates, not just from one regulatory agency, but from a multitude of agencies and standards: FDA, EMA, ISO 13485 and ISO 11607, the last of which is about packaging for terminally sterilized medical devices.

Nature of changes to the regulation of medical devices

To state that the upcoming changes are of a profound nature is to make an understatement. Look at the extensiveness of the proposed changes:

  • Starting 2016 and running through 2017; the FDA has released over ten new guidance documents for medical devices, with renewed focus on risk assessment;
  • The 2016 update of the ISO 13485 incorporates risk management into every aspect of medical devices' QMS from 2019;
  • The European Commission has ratified many new regulations for its medical device regulations (MDR).

The European Commission has ratified many new regulations for its medical device regulations (MDR).

Both the FDA and the EMA require added focus on submissions

Both the FDA and the EMA have brought in added requirements relating to the crucial area of submissions. Brought in with the intention of increasing the safety of the use of medical devices, these regulatory updates have expanded the regulatory requirements for product performance and safety from manufacturers. The FDA makes the submission process for medical devices, known as the 510 (K), even more stringent and longer than it is.

The MDR, on the other hand, places higher emphasis on clinical assessment and postmarket traceability along the supply chain of the medical device with these regulations. The core area in which the new changes have impacted companies in the medical device area is that starting from 2020, medical devices should demonstrate the efficacy of medical devices by meeting predetermined clinical safety for both existing and new devices. This means that the number of clinical trials will go up dramatically.

Effects of the new regulations on the medical device industry

What does all this mean to the medical device industry? The industry is sure to go through a churn. A direct fallout of this decision is that medical device companies will now have to think about how to fund their already expensive clinical trials. It is going to cost them millions of dollars to finance these new trials, not to speak of the innumerable regulatory steps they must comply with at every stage

This means that the cost of doing business will go up, triggered by the need to carry out more and more clinical trials, as we have just examined. This is going to make the cost of entering or staying in the industry pretty challenging.

Existing and new medical device companies will think twice about the prospects of continuing in the trade. They either remain in the business and innovate to stay ahead of the pack, or they opt out, if they feel that the ROI is not proportionate to the money they put in. The race for putting their new product out into the market ahead of the competition will intensify. Medical device companies will be in a piquant situation of losing out on a product after all the efforts of a clinical trial, if they are not able to get it out on time.

Yet, this is a market not to be missed out on

This is not to suggest that the scenario is going to be grim in the future. The aim of these updates is to facilitate greater visibility into the products by introducing new requirements, something that was lacking with existing systems. Once medical device companies adapt these changes, they enhance their systems to accommodate these crucial issues. They are also in a better position to innovate.

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