Harmonized standards and the countdown to the MDR

Standards writers for medical devices, in particular anaesthetic and respiratory devices, are concerned about the EU Commission’s timelines for harmonized standards.  Especially considering that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) has been happening over a number of years.  

As of May 2020, which is fast approaching, there will be no harmonized standards for anaesthetic and respiratory medical devices or for any standardized medical device. Attempts to push the issue have been unsuccessful as there is no “Standards Request,” or as it used to be called a Mandate, giving permission to write an annex ZA in standards listing the General Safety and Performance Requirements (GSPR) and the requirements in the standard that meet that GSPR. There are HAS consultants, previously CEN consultants, in the wings all trained and ready to go but with nothing to assess. There is supposed to be a harmonization trial using what are called horizontal standards i.e. those standards that affect most medical devices such as Risk management, Usability, General safety for medical electrical equipment etc. but nothing for device specific standards, which are also needed by manufacturers so that they can CE mark their devices.

Meanwhile it seems that medical devices are being CE marked and sold in Europe despite there being no harmonized standards and patients are not facing increased risks proving that pragmatism reigns. Notified Bodies that were able to make the transition from the MDD to the MDR are using standards to assess whether medical devices are fit for purpose, as they are deemed to be the state of the art.

It does not look like this situation will change any time soon so it begs the question why harmonize medical device standards at all, how does it help the manufacturer and how does it make it a safer place for the patient?

Terry Longman is an independent consultant on matters relating to standards and specialises in anaesthetic and respiratory equipment. He is on several committees at national, European and international levels with over 40 years' experience in the medical equipment industry.