The new Medical Device & In-vitro Medical Device Regulations are now available in the Official Journal, having being published as
- Regulation (EU) 2017/745 Of The European Parliament and of the Council of 5th April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
- Regulation (EU) 2017/746 Of The European Parliament and of the Council of 5th April 2017 on in vitro diagnostic medical devices, and repealing Council Directives 98/79/EC Commission Decision 2010/227/EU.
The clock is ticking the countdown has started!
Where to go from here?
The new Regulations have a transition period of 3 years for Regulation 2017/745 and 5 years for Regulation 2017/746, with full application of Regulation 2017/745 in 2020 and full application of Regulation 2017/746 in 2022.
At the time of full application all CE Marked devices placed on the EU Market must be in compliance with the above named regulations.
However devices compliant to the current relevant Directive and placed on the market prior to full application of the Regulations can remain active to the validity of their certificates, (latest date 2024, 4 years post full application for medical devices & 2 years post full application for in vitro diagnostic medical devices) provided there are no changes made to the device following date of full application of the regulations. The post market surveillance activity, vigilance and registration of economic operator requirements of Regulation 2017/745 will apply to all devices on the market after 26th May 2020 (time of full application).
So what does a manufacturer need to do?
Determine if your device is a medical device or a product without an intended medical purpose referred to in Annex XVI
- Determine the classification of your device per the requirements of Chapter V & Annex VIII, (Class I non-sterile, non-measuring and non- reusable surgical instrument medical devices and Class A in vitro medical devices do not require the intervention of a Notified Body)
- Identify the general safety and performance requirements that apply to your device (s) per Annex I
- Identify the harmonised standards and common specifications required to demonstrate compliance to the general safety and performance requirements applicable to your device(s)
- Determine the conformity assessment route appropriate to your device(s) Annexes IX, X or XI as appropriate
- Determine the Technical documentation required to demonstrate compliance to the general safety and performance requirements applicable to your device(s)
- Develop your technical documentation in compliance to the above requirements per Annex II
- Review your post market surveillance, vigilance and market surveillance systems per the requirements of Chapter VII
- Develop your post market technical documentation per the requirements of Annex III
- Review your clinical evaluation and clinical investigations for compliance to Chapter VI 2017/745 for medical devices and clinical evidence, performance evaluation and performance studies for compliance to Chapter VI 2017/746 for in vitro diagnostic medical devices
- Review your clinical evaluation and post market surveillance for compliance to Annex XIV 2017/745 for medical devices and interventional clinical performance studies and certain other performance studies for compliance to Annex XIV 2017/746 for in vitro diagnostic medical devices
- Review your clinical investigations per the requirements of Annex XV 2017/745 for medical devices
- Draw up your declaration of conformity in compliance to Annex IV
- Develop your UDI –DI and UDI-PI
- Obtain an SRN
- Apply to a duly designated Notified Body under Regulation 2017/745 &/or 2017/746
What has the Notified Body to do?
Revaluate the Notified Body Quality Management System in line with the requirements of 2017/745 & / or 2017/746
Apply for designation under 2017/745 & / or 2017/746
- Liaise with the manufacturers to ensure a thorough understanding of the requirements by all economic operators