Support for Your Medical Device Regulation Compliance Transition
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.
The transition to the new MDR can be overwhelming if you do not have the resources required to support it. This is where Oxford can partner with you!
Through our established network of compliance experts within the device sphere, we can support clients of all sizes – from start-ups to multinational market leaders. We can provide recruiting and consulting support for every stage of the MDR compliance transition process.
Read how a European medical device manufacturer was able to progress towards MDR compliance with Oxford’s expertise.
Understanding 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.
Key Changes
- 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
With MDR being one of the most significant updates to the regulations that govern medical devices in Europe, it will involve widespread changes in how devices are manufactured and the level of compliance and clinical data required to bring them to the European market.
2017
May 26th
Official entry into force of MDR 2017/745 and IVDR 2017/746.
November 26th
Notified Bodies may apply for designation under MDR and IVDR.
2021
May 26th
MDR date of application.
Compliance with the new MDR is mandatory for medical device manufacturers who want to continue to market their devices in the EU after May 2021.
2022
May 26th
EUDAMED* that aligns with new MDR released for use.
May 26th
IVDR date of application.
Compliance with the new In Vitro Diagnostic Regulations (IVDR) is mandatory for medical device manufacturers who want to continue to market their devices in the EU after May 2022.
2024
May 26th
AIMD, MDD and IVDD certificates become void; after this date devices will no longer be approved for the EU market under these certificates.
2025
May 26th
Devices can no longer be put into service in the EU using AIMD, MDD or IVDD certificates.
*EUDAMED is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.
Oxford's MDR Process
Oxford's Experts
- Compliance experts in medical devices, ISO 13485, and 14971 and the newly published MDR
- Experts in Technical File and CER compilation for all classes of medical devices
- Specific device product knowledge from Orthopaedic to Cardiovascular, Drug Delivery, Software Devices, and IVDs
- Lead auditor consultants who have held senior positions for notified bodies and regulatory agencies such as the FDA
- Consultants who have held manager and director level positions for many of the major manufacturers within medical devices