MDR & IVDR

MDR

By 26-May 2021 (recently postponed from May-2020), Medical Devices companies that wants to sell their products in the European marketplace, will have to comply with the new EU Medical Device Regulations (MDR) which is a new set of regulations governing production and distribution of medical devices in Europe.

Several devices not covered by the previous Medical Device Directive (MDD) requirements now fall under the MDR requirements, and many cases, the devices need to be re-classified.

MDR will replace the existing Medical Device Directive (92/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).

The main reason for MDR is to ensure high standards of quality and safety for medical devices being produced in or supplied into Europe.

The regulation holds amongst other several new requirements that must be adhered to:
  • Even for Class I devices, an ISO 13485:2016 compliant Quality Management System (QMS) is now required.
  • New Medical Device Classifications and system supported by the Conformity Assessment
  • Registration and communication related to the Authorized Notified Body with an agreed mandate
  • Registration in the European database on medical devices (EUDAMED)
  • Labelling (CE) and UDI (Unique Device Identification) documentation and maintenance.
  • Post-Market activities, such as implementation of a surveillance system and a system for reporting incidents and safety corrective actions.
Pharma IT can offer a scalable turn-key solution and services that will support and enable startups, spinoffs, small and medium sized medical device companies to comply with the new regulations listed above.   We are ready to support the new quality and regulatory requirements that must be met throughout the whole medical device lifecycle:
Larger or more complex medical devices companies, pharmaceutical companies and biotech companies might benefit from other solutions, as such Pharma IT also work as an agnostic system adviser.

The Pharma IT scalable turn-key solution and services can be delivered individually or as a package deal. In this article we have listed the minimum required effort to implement our solution assuming companies will do more work on their own, but additional services can be provided by Pharma IT on an ad-hoc basis, see figure below.

As a starting point, here are some questions you should ask yourself:
  • Do you maintain a QMS which is ISO 13485:2016 compliant?
  • Do you have a system for Risk Management?
  • Have you determined the risk classification of your existing and/or new devices according to the new MDR classification roles?
  • Are you able to assume the responsibility for compliance with MDR?
  • Has the labelling of your current products been checked against the new requirements?
  • Have you reviewed the clinical evidence for your current devices against the new requirements?
  • Have you identified the reporting requirements involving EUDAMED?
  • Do you have Post Market Activities in place?
If the answer to any of these questions are ‘I don’t know’, ‘maybe’ or ‘no’ then reach out to Pharma IT and we will be able to help you.

IVDR

For In Vitro Diagnostic Medical Devices Regulation’s (IVDR, Regulation (EU) 2017/746) the corresponding date of application remains the same (May 2022).
The regulation holds several new requirements that must be adhered to:
  • Implementation of a Quality Management System, with a Conformity Assessment
  • New classification system supported by the Conformity Assessment
  • Requirements for CE marking on the device supported by technical documentation
  • Compliance with reporting of clinical investigations and post-market surveillance requirements
  • Appointing an Authorized Representative that is responsible for regulatory compliance

Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to 26 May 2022 to meet the requirements of the IVDR.

Products already certified by a Notified Body may be placed on the market for further 2 years under some conditions, e.g. the certificate issued under the IVDD is still valid and subject to surveillance by the Notified Body who had issued it.  This provide that no significant changes to the product are made.

Pharma IT can offer a scalable turn-key solution and services that will enable small and medium size medical device companies to comply with new regulations listed above.

Larger or more complex medical devices companies, pharmaceutical companies and biotech companies might benefit from other solutions, as such Pharma IT work as an agnostic system adviser.

The Pharma IT turn-key solution and services can be delivered individually or as a package deal. In this article we have listed the minimum required effort to implement our solution assuming companies will do more work on their own, but additional services can be provided by Pharma IT on an ad-hoc basis, see figure below.

Meet the Medical Device team:

Senior Pharma Consultant
Bettina Kok

Bettina Kok holds more than 15 years’ experience in the medical device industry working with a broad selection of projects in QMS, IT QMS, QA, Pharma IT projects and GDPR. Bettina holds in total 17 years’ experience working under various standards and directives with compliance and documentation, in highly regulated industries. Experience as a Compliance Manager, RA Consultant, Compliance Architect, Vigilance and Complaint Specialist and Track Lead (URS) on IT projects. Hands-on experience with IT and QMS documentation, process mapping, design and implementation of quality processes, to improve and secure compliance requirements.

Bettina has several years of experience with QMS systems preferred in medical device/pharma, ISO 13485 and ISO9001 compliant businesses. Such systems are for example: HIQMS, DOORS, ENOVIA, Track-Wise, Sharepoint, Improve, Veeva and Lotus Notes.

Risk Management, Document Management, Quality Management, Auditor, MDD 93/42 Compliance, EU GDPR, Data Protection Impact Assessment (ISO/IEC29134), Information Privacy Manager (IAPP)
Director, Medical Device
Per Andersen

IT Project Manager/Architect with 20+ years of experience within pharmaceutical and medical device industry. Experience with infrastructure, Complex IT applications, ERP-Systems, BPM&N, WebServices, medical devices and Software as medical device software

Jira foundationals - Agile Development, Atlassian; Jama Foundationals, Requirements, Risk and Test Management; SAFé Agile / Scrum

Meet the MDR & IVDR team:

Senior Pharma Consultant
Bettina Kok

Bettina Kok holds more than 15 years’ experience in the medical device industry working with a broad selection of projects in QMS, IT QMS, QA, Pharma IT projects and GDPR. Bettina holds in total 17 years’ experience working under various standards and directives with compliance and documentation, in highly regulated industries. Experience as a Compliance Manager, RA Consultant, Compliance Architect, Vigilance and Complaint Specialist and Track Lead (URS) on IT projects. Hands-on experience with IT and QMS documentation, process mapping, design and implementation of quality processes, to improve and secure compliance requirements.

Bettina has several years of experience with QMS systems preferred in medical device/pharma, ISO 13485 and ISO9001 compliant businesses. Such systems are for example: HIQMS, DOORS, ENOVIA, Track-Wise, Sharepoint, Improve, Veeva and Lotus Notes.

Risk Management, Document Management, Quality Management, Auditor, MDD 93/42 Compliance, EU GDPR, Data Protection Impact Assessment (ISO/IEC29134), Information Privacy Manager (IAPP)
JakobJuulRasmussen
Partner, Management Consultant
Jakob Juul Rasmussen
+ 45 24 34 26 55

IT Program/Project Manager with 16 years of experience within the pharmaceutical industry, finance and the public sector. Experience with infrastructure, service delivery management, application development, SOA and SAP projects

Project and Program Management certified in IPMA level A, PMP, MoP, PRINCE2, MSP and Professional SCRUM master