p36.labs udi platform factsheet · unique device identification (udi) now and in future. the udi...
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Medical Device manufacturers across the globe must comply with various regulations on
Unique Device Identification (UDI) now and in future. The UDI Platform by p36.labs tackles
the challenge of global UDI compliance with a unique multi-agency concept. Based on SAP´s
best-in-class Cloud Platform, we provide a Managed Service for UDI Data Maintenance and
Submission Management for the Medical Device Industry.
EU MDR compliance The EU Medical Device Regulation (MDR)
with its various aspects currently is a huge
challenge for all Medical Device
manufacturers; same applies for all In-
vitro diagnostics manufacturers with the
corresponding IVDR.
One of the core elements is Annex VI of
legislation 2017/745 on Unique Device
Identification (UDI), forcing all
manufacturers and labelers to submit
their Device data to the EUDAMED
database. Date of application for
legislation 2017/745 is May 26, 2020, for
IVDR (in 2017/746) is May 26, 2022 – the
clock is ticking, and you as a Medical
Device manufacturer or labeler must act
now to ensure your EUDAMED readiness.
Global UDI challenge Thus, the current focus is the timeline for
the Medical Device Regulation (MDR) in the
EU. Global Medical Device manufacturers
are already familiar with Unique Device
Identification concepts as this was first
introduced by the Food and Drug
Administration (FDA) in the United States
in 2014.
Now, most Life Sciences companies are
aware that UDI is going to be a global
challenge beyond EU MDR with more
regulations to come – hence assessing
their IT-systems to cover requirements for
UDI regulations beyond EU and the United
States. UDI regulations will remain an
ongoing task, requiring Software-
supported processes to cope with change
requests and upcoming new regulations
from other authorities worldwide - so it´s
time for a strategic setup for UDI.
Achieve UDI Compliance
with the UDI Platform Cloud based, future-proof and natively SAP-integrated
The UDI Platform is recommended
by SAP for fast UDI Compliance.
UDI as a service
You will need a Software solution for
maintenance and submission of UDI
related Product Master Data in order to
remain compliant to Medical Device
regulations across the globe. From a
technical perspective, market-leading
manufacturers implemented a Cloud-first
approach in the last years and actively
demand a managed SaaS UDI solution.
The UDI Platform by p36.labs offers the
cloud-based answer to your UDI
challenge. It allows you to meet the
requirements of regulatory agencies
around the world – fast, flexible and easy
to use. The UDI Platform is a SaaS solution
natively built and operated on SAP Cloud
Platform that integrates seamlessly into
your existing hybrid IT landscape.
Multi-agency capability
The UDI Platform was designed from
scratch to handle the different data
models of various regulatory authorities
with their specific required attributes,
validation rules, different data exchange
formats and submission handlings. Based
on the SAP Cloud Platform capabilities,
our solution allows you to re-use your
existing Product master data from both
SAP and Non-SAP source IT systems.
Missing data can be enriched within Fiori
based User Interfaces in a controlled and
traceable way – all maintenance
processes are based on Workflows and
Modern User Experience in a
robust SaaS environment
can be easily adapted to the processes in
your organization. This is even true for the
User Interfaces which can be adapted by
configuration for every role and Workflow
step. Any information can be returned to
your source IT systems in a secure way, so
you can break down data silos while
leveraging a best-of-breed approach on
UDI. The UDI Platform includes the
submission handling and a unified status
handling in order to provide a
comprehensive reporting of UDI
submissions status and market
compliance.
Content Packages You can use the UDI Platform as central System for all UDI related maintenance and
submission processes of multiple regulatory authorities. Starting with FDA and EUDAMED,
p36.labs builds Content Packages for each upcoming regulatory authority1 and provides
them as Solution extensions on top of the UDI Platform Core. The Content Packages consist
of:
• Implementation of latest data models
• Standard delivery of validation rules and changeability rules
• Standard provisioning of submission interfaces
• Reporting of data and submission status
For EUDAMED, our Content Package does already include standard processes to cover the
requirements on Basic UDI and is capable to handle the submissions of legacy devices.
1 p36.labs plans to offer Content Packages for all UDI databases worldwide within a reasonable time, if this is not ruled out by regulations of the respective country or region. p36.labs will proactively inform customers about the upcoming availability of further agencies in its Release Plans.
UDI Platform at a glance
p36.labs, a Business Unit of
projektraum36 GmbH & Co. KG Badestube 9 36251 Bad Hersfeld, Germany
Phone: +49 6621 – 7954500
E-Mail: [email protected]
Managed Service
UDI is not a one-time task; it is going to be
an ongoing process in your company.
Together with our partners we are
monitoring the market requirements and
take action when new requirements arise.
Specific changes of existing authorities
are implemented timely and provided into
your Cloud solution account in order to
stay compliant in a market. New regulatory
authorities and their UDI Databases are
covered by new Content Packages
delivered on top of the UDI Platform Core
and can be ordered if you operate in the
affected market. Our continuous
compliance support enables you to
validate the UDI Platform Software
solution and to keep the qualified state for
the environment on the underlying Cloud
Platform.
Validation
Chemgineering Business Design is our
partner for all compliance topics.
As experts for validation and qualification,
Chemgineering supports your way to the
cloud. Based on our continuous
compliance support, Chemgineering has
created a Validation Package which
complements our portfolio. It is based on
a CSV approach adapted to the UDI
Platform and the specific requirements of
the medical device industry to introduce
and operate the UDI Platform Solution in
accordance to the regulatory
requirements in Europe and overseas.
Contact us! Get support from our UDI experts! Contact us in order to get
more information and see a live demo. Send us a short
message to [email protected].
About p36.labs p36.labs is a Business Unit of projektraum36, a German based SAP Partner company focusing
on SAP Cloud Platform solutions. p36.labs builds and runs cloud-based solutions for the Life
Sciences industry with focus on native SAP Integration. p36.labs has strong SAP Cloud
technology background and expertise in Unique Device Identification (UDI) topics since 2012.