Medical Devices Regulation (EU) 2017/745
Notified Body 2460
On 5 May 2017, two new Regulations on medical devices were published, and they entered into force on 25th May 2017. The Medical Devices Regulation date of application is from 26th May 2020 meaning compliance is mandatory to be able to place Medical Devices on the European market from this date. In vitro Diagnostic Medical Devices Regulation applies from 26 May 2022.
Medical Devices Regulation (EU) 2017/745 will replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD). Both regulations bring a series of important improvements to conformity assessment for medical devices with the intention to:
- Improve the quality, safety and reliability of medical devices placed on the European market.
- Strengthen transparency of information related to medical devices for consumers and practitioners.
- Enhance vigilance and market surveillance of devices in use.
The extent to which these changes will affect your operation will depend on the type of device manufactured and the role you hold (manufacturer, importer, authorised representative). It is however anticipated that in most cases significant changes must be made to compliance process and technical documentation and successfully implemented in operation before compliance with the regulations can be achieved.
MDD Recertification or MDR Initial Certification – The key choice facing manufacturers in 2019
Notified Bodies, notified according to the existing Medical Device Directive may continue to issue certificates against these requirements up to and including 25th May 2020. From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC (Active Implantable Medical Devices) and 93/42/EEC (Medical Devices) shall become void. These MDD certificates will be valid until their original expiry date, or 26th May 2024, whichever is sooner. This means that manufacturers could continue to put MDD certified devices on the market up to and including 26th May 2024, assuming they continue to keep these certifications valid. As the requirements for MDR are in many cases, significantly more onerous than MDD, we expect that manufacturers with MDD expiry dates in the first years after applicability of MDR will decide to re certify out of normal cycle to maximise market access time according to the current MDD requirements.
Designation update:DNV GL Presafe AS (Notified Body 2460) has applied to be designated as a Notified Body in Norway under Medical Device Regulation (EU) 2017/745 with the same scope as our existing MDD designation. In November 2018 we completed our audit from the Norwegian Medicines Agency and Joint Assessment Team. The European Commission has not yet announced its plans for designation timelines and we will update this information as soon as this becomes known.