Date(s) - 06/09/2018
1:00 pm - 5:00 pm
Understanding MDR’s impact on your supply chain processes
The European Medical Device Regulations 2017/745 (MDR) was published May 5, 2017 in the Official Journal of the European Union, replacing current MDD and AIMDD regulations. Although full implementation is far in the future (2020) early action is required, as MDR will have mayor impact on all economic operators* in MD&D’s supply chain networks. Given the complexity of these new regulations, economic operators should define transition strategies depending on several factors. Extensive and detailed planning will therefore be key in the successful deployment of these strategies.
Supply Chain planning impact
Although not exhaustive the following list provides some insight in the impact of MDR on supply chain planning and related processes:
- Monitoring and management of inventories (warehouse inventories, kit inventories, consignment inventories, etc.) of
pre-MDR and MDR registered products;
- Forecasting & demand management will need to be able to handle pre-MDR and MDR approved products;
- Product Life Cycle Management (PLCM) is drastically impacted as old and new products will need to be phased out and phased in. The timing however is depending on a lot of factors: e.g. expiration dates of current CE marking certificates, availability of clinical data, availability of notified bodies, expiration dates of devices, inventories (including consignment stocks), production readiness etc. An intensive risk management process will be required on all the above-mentioned factors.
- E2E Supply Chain transparency will become increasingly important, as manufacturers must prove that they are in full
control of their supply and distribution chains;
- Tracking and tracing of unique articles throughout the E2E supply chain is required under MDR, so also for this requirement
extensive adjustments of IT systems will be needed;
- Extensive adjustments of information systems and production lines are needed to implement the Unique Device Identification (UDI) and other new labeling requirements. Under the new MDR regulations registration at item level is required at all economic operators in the supply chain, so sole registration on batch level is not sufficient anymore.
More discussion about this subject should however lead to a more comprehensive overview on the impact of MDR on the supply chain planning processes within MD&D’s value chains.
Although the new MDR looks very QA/AR related (e.g. Post Market Surveillance, QMS changes, integration with EUDAMED databases, ….) the impact on supply chain planning should not be underestimated and this subject should be very high on your priority list. Probably you and your team are already involved in defining transition strategies for dealing with this, but to make the impact of MDR even more transparent we invite you to this special event to share knowledge around this theme.
The goal of this international event is to give all participants a good understanding of the MDR regulations and their impact on supply chain planning, and to develop a solid base for defining or improving existing transition strategies. During the event you can share your challenges around the new MDR with your peers.
12.00-13.00 Welcome with lunch
13.00-13.15 Kick off
13.15-14.30 Understanding MDR regulation
14.30-15.00 Introduction on supply chain impact
15.00-16.30 Participant discussion on supply chain planning impact in the MD&D value chain
16.30-17.00 Evaluation & closing
17.00-18.00 Drinks and networking
Details of the event
|September 6th, 2018 – 13.00 – 17.00 hrs|
|Brussels airport Zaventem, Belgium|
|Free of charge|
Please reserve your seat today by e-mailing Kim van Broekhoven at firstname.lastname@example.org.