Navigating EU MDR
Recently, the European Commission introduced REGULATION (EU) 2023/607 which amended MDR/IVDR by introducing an extension to transitional timelines for certain legacy medical devices.
As per the amendment
Certain eligible Medical Devices and In-Vitro Diagnostic Devices will follow these timelines:
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Class III Implantable custom-made devices: May 26 2026
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Class III & Class IIb implantable devices: 31st December 2027
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Class IIb non-implantable: December 31 2028
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Class IIb sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors : December 31 2028
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Class IIa and Class I (Is/Im): December 31 2028
And benefit from
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Extended validity of certificates issued up to May 26 2021
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Removal of the 'sell-off' date for MDR & IVDR
While this is welcome news for some manufacturers,
What should ‘other’ Medical Device and IVD manufacturers do whose devices are not covered under these amendments?
Irrespective of the amendment, all Medical Device manufacturers and IVD manufacturers need to abide by and comply with the MDR and IVDR, which remain until May 26, 2021, and May 26, 2022, respectively.
If your medical device is not covered under the amendment criteria, here is a step-by-step guide to comply with EU MDR / IVDR:
- Step 1: Classify your medical device
- Step 2 : Review and update technical documentation
- Step 3 : Implement a quality management system [QMS]
- Step 4 : Appoint an EU Authorised Representative EUAR/ Person Responsible for Regulatory Compliance PRRC
- Step 5: Register with EUDAMED
- Step 6 : Ensure compliance with Unique Device Identification (UDI)
- Step 7: Implement Post Market Surveillance
- Step 8: Contact our EXPERTS!!!
Begin your Navigation now!
- Step 1: Classify your medical device
The EU MDR / IVDR categorise Medical Devices into 4 risk classes. Through product classification, you can determine the risk level and check for relevant regulatory risk requirements. It is important to ensure that you have accurately classified your devices, as this will impact the rest of the compliance process.
- Step 2 : Review and update technical documentation
EU MDR and EU IVDR require robust technical documentation. As a manufacturer, it’s a legal requirement to ensure that your product’s technical documentation is up to date and comply with new requirements. These technical documents include risk management, clinical evaluation details, labelling and Instruction for use [IFU] documentation.
- Step 3 : Implement a quality management system [QMS]
To comply with the EU MDR, you must implement a quality management system (QMS) that meets the requirements of the regulation. Your QMS should cover all aspects of device design, development, manufacture, and distribution. It should also include procedures for post-market surveillance, complaints handling, and vigilance reporting. Implementing a QMS can help you to ensure that your devices are safe and effective, and can demonstrate your commitment to patient safety and quality. A common QMS used by medical device companies is ISO 13485.
- Step 4 : Appoint an EU Authorised Representative EUAR/ Person Responsible for Regulatory Compliance PRRC
Appointing an EU Authorised Representative is a mandatory requirement for manufacturers based outside of the EU. An EUAR will share the same liability as a manufacturer and be the first point of contact for any regulatory changes in the EU market.
Apart from EU AR, medical companies within the EU need to appoint a Person Responsible for Regulatory Compliance [PRRC]. The PRRC is responsible for maintaining all regulatory requirements and should be at the company’s disposal 24/7.
Depending on the status and location of your company, appointing a EUAR or PRRC is a mandatory requirement.
- Step 5: Register with EUDAMED
EUDAMED is the central database for medical devices in the European Union. Under the EU MDR, all medical devices must be registered with EUDAMED. This includes information such as device identification, classification, and manufacturer details. Registering with EUDAMED is a crucial step towards compliance with the EU MDR.
- Step 6 : Ensure compliance with Unique Device Identification (UDI)
The EU MDR requires all medical devices to have a Unique Device Identifier (UDI). UDIs are used to identify and track devices throughout their lifecycle. It is important to ensure that you have a system in place for assigning and managing UDIs for your devices. This will help you to comply with the EU MDR and ensure that your devices are traceable and identifiable.
- Step 7 : Implement Post-Market Surveillance
Post-market surveillance (PMS) is an important aspect of the European Union Medical Device Regulation (EU MDR) that applies to all medical devices marketed within the European Union. PMS is the ongoing process of monitoring the safety and performance of a medical device after it has been placed on the market in order to identify and mitigate any potential risks associated with its use.
- Step 8 : Contact our EXPERTS!!!
Following all the above steps will help you comply with RAQA requirements listed under EU MDR / IVDR, but it doesn’t ensure all-round protection. Experts at Med-Di-Dia have 25+ years of cumulative experience in providing end-to-end support for all Regulatory and Quality Compliance requirements.
Contact the experts by clicking on the link here!
Do not navigate the Regulatory maze all alone!
Our experts can cut to the chase and support faster, smoother and easier compliance with EU MDR / IVDR
Drop us an email on mdd@mddltd.com or simply leave your details via this link, and we shall contact you as soon as possible!
We are here to be your Regulatory Risk Partner for Medical Devices, Diagnostics and Digital Health!
