In May 2017, the European Commission voted to approve new Medical Device Regulations (2017/745). This is one of the most signiﬁcant updates of the regulations that govern medical devices in Europe in recent history. It has and will continue to involve widespread changes in how devices are manufactured and the level of compliance and clinical data required to bring them to the European market.
What are the New Medical Device Regulations (MDR)?
The new Medical Device Regulations (2017/745) approved by the European Commission in May 2017 will necessitate widespread changes in how devices are manufactured and the level of compliance and clinical data required to bring them to the European market.
All medical device organizations that serve the EU market need to consider how they will transition in time to meet the required MDR compliance deadlines. This will require drafting a transition plan for each of your devices and for your organization as a whole, and then dedicating the resources needed to fulfill the new requirements.
What are the Key Changes to be aware of?
- More effective Post Market Surveillance requirements
- More detailed requirements and clinical evidence for Clinical Evaluation Reporting
- QP type Responsible Person for product release must be designated for manufacturers
- Increased level of compliance for UDI & labelling
- Distributors & importers must now be regulated (MDR Arts 11-14)
- IVD risk-based classification leading to many more devices falling under Notified Body scrutiny
Key Dates to Remember for the New Medical Device Regulations (MDR)
Define the MDR Process and Find the Right Partner Early
Working towards MDR compliance is a big task. To ensure MDR compliance into 2022, and beyond, plan ahead. Identify your internal team and any partnerships that you may need. A consulting services partner that is well versed in MDR to assist your organization is an important consideration. A process similar to the one below should be part of the entire strategy.
Understanding MDR, its impact on your organization, the key changes, and the imperative dates is all part of having a proactive approach to compliance. For all organizations manufacturing devices with the intent to bring them to the European market, the impact of MDR will continue to evolve as companies adapt, ensure compliance, and get ahead of the deadlines.