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: info@p36labs.com

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 info@p36labs.com.

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.