Today is 26 May 2020. To some, just another Tuesday coming to terms with post-bank holiday blues, but for those in the medical devices industry, today’s date has been ingrained for years as the day upon which the Medical Device Regulations 2017/745 (MDR) were supposed to come into force. However, back in March, the European Commission took the decision to postpone the implementation of the MDR for one year until 26 May 2021, in response to the ongoing COVID-19 crisis.
Previous On the Pulse articles have discussed various aspects of the challenges posed by the MDR; in particular, the level of preparedness for its intended entry into force today. The MDR introduces a number of high-profile changes to the existing framework, set out in the Medical Devices Directive 93/42/EEC (MDD).
As the MDR’s entry into force approached, concern in the industry began to escalate, as set out in earlier On the Pulse articles. This concern was two-fold. Firstly, the MDR increased the demand for Notified Bodies. The MDR does not include any ‘grand fathering’, meaning that all devices need to be certified in accordance with the MDR before being ‘placed on the market’ (subject to various transition periods). In addition, the MDR up-classifies various class I devices, which will require a Notified Body for the first time, along with the products with a non-medical purpose set out in Annex XVI (such as dermal fillers).
The second part of the problem was that, despite this increased demand for Notified Bodies, only a fraction of the Notified Bodies designated under the outgoing MDD have been re-designated for the incoming MDR. Implementation of the MDR from today would have presented significant challenges to Notified Bodies attempting to cope with far larger application-volume and created a bottleneck which would likely have resulted in fewer medical devices on the market, which could most importantly have had a knock-on effect for patients.
Medical device manufacturers would be well-advised to take this extra 12 months to prepare for full compliance with the MDR. Moreover, this delay will hopefully provide an opportunity for the European Commission to ensure that a sufficient number of Notified Bodies have been designed before 26 May 2021. Although 26 May 2020 will pass without particular note (except perhaps a faint wistfulness for the weather of the long weekend just gone), a medical devices certification bottleneck could well have just been averted.