EU MDR and IVDR Compliance

The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

Medical device manufacturers must comply with MDR by May 26, 2020 and IVDR by May 26, 2022.

USDM Life Sciences offers both managed services and project-based solutions to help plan, execute, and manage any or all enterprise-wide activities necessary to meet European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) requirements.

EU MDR and IVDR Compliance Solutions:

Gap assessment and product portfolio rationalization
Economic Operator (EO), device registration, and UDI Database submissions
Assess devices with valid MDD / AIMD certificates that will be distributed after 2020
Assess devices that will be (re)certified to the MDR
Assess Class I devices and systems and procedure packs that must be MDR compliant by 2020
Assess EO: assess AR, importer, distributor compliance (enhanced responsibilities of other economic operators – including traceability)
Assess QMS (ISO 13485:2016 as standard), identifying additional SOPs or changes to existing SOPs required to manage EU MDR, including UDI

European Databank on Medical Devices (EUDAMED) Submission Solutions:

Organizational Readiness Assessment for EUDAMED

Complete assessment of supply chain and regulatory activities required to support the submission of data to EUDAMED
Inventory of medical devices subject to EUDAMED regulatory requirements for further assessment
Identify process improvements to support the submission of data to EUDAMED
Assess the overall readiness of the organization to meet EU regulatory organization to meet EU regulatory reporting requirements

System Validation for EUDAMED

Conduct system validation activities required for EUDAMED submissions
Identify any system integration issues and recommend corrective actions
Identify process and documentation improvements necessary to meet EU regulatory requirements
Deliver system validation activities and documentation for new or modified systems

UDI Data Validation for EUDAMED

Conduct validation activities on the data required for EUDAMED submissions
Identify any data integrity concerns that may delay EUDAMED that may delay EUDAMED submissions
Assess areas for improvement to prepare for and expedite data submissions to EUDAMED

FAQ

Does MDR and IDVR only apply to companies based in the EU?

The MDR and IVDR apply to a medical device placed on the EU market after the applicable Date of Application (DoA). Moreover, many other countries also leverage a CE mark for market authorization. Also, the MDR also added a lot of products (Annex XVI) that, though they have no specific “medical” purpose (e.g., cosmetic content lenses), are now also regulated as devices.
Do you have an MDR 2020 compliance guide?

USDM has a number of templates and other tools that we use with clients during MDR/IVDR implementation.
Do medical device companies in the UK need to be MDR/IDVR compliant?

In preparation for Brexit, the UK has published its own version of the MDR/IVDR, which completely mirrors the EU versions. Moreover, since the UK will not be part of the EU, companies outside of the UK will also need a UK “responsible person” – much like an EU Authorized Representative (AR). For companies based in the UK, they will now need an AR and importer to place products on the EU market.
Does the EU MDR and IVDR supersede all other EU medical device regulation legislation in place?

Yes, the MDR supersedes both the Medical Device Directive (MDD) and the Active Implantable Device Directive (AIMD). The IVDR supersedes the IVD Directive (IVDD).

What will happen if I’m not EU MDR/IDVR compliant by the deadline?

There are MANY aspects to compliances, with may varied compliance timelines. However, in general, you cannot place a product on the EU market after the DoA if it is not appropriately compliant.
How do I train my company for EU MDR/IDVR compliance?

Again, there are many aspects to compliance. And, in general, all parts of your organization will have some role and responsibility. USDM can help provide both general and specific training on the MDR and IVDR. Contact us here.
Can USDM help me with EU MDR/IDVR gap analysis?

YES! USDM is a trusted expert in regulatory compliance gap assessments and would be happy to discuss your needs. Contact us here.