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EU MDR

Preparing businesses for the new medical device regulation in Europe.

What is EU MDR?​

The EU Medical Device Regulation (MDR – 2017/745) entered into force in May 2017 and will reach its full implementation in May 2020. EU MDR requires all companies that market devices in the EU to ensure not only compliance but also an efficient implementation of internal adequate processes, technology, and documentation according to the new regulation.

The first important step to compliance is to identify your process and technology gaps, conduct a risk assessment, and clarify new necessary documentation. With NNIT’s deep roots in the life sciences domain and vast experience with assisting life science companies along their journey to compliance, we have the foundation to help you in your adoption of MDR.

NNIT has developed an EU MDR package consisting of an end-to-end consulting methodology, 5-phased framework, and an EU MDR Assessment Tool. Additionally NNIT has scoped all requirements and categorized them into 5 logical categories. This package helps you discover all of the new relevant MDR initiatives (2017/745) for your organization and thereby avoid redundant work and costs as well as delayed compliance.

Example of requirements impacting device producing companies:

• Changes in the classification of devices and extension in scope.
• A new public data base will be introduced by the EU Commission named Eudamed. In Eudamed, device data and UDI shall be uploaded.
• Establishment of UDI (Unique Device Identification). UDI provides a foundation for systems and processes to enhance traceability and patient safety.
• New Risk Management System grounding on the ISO 14971 standard.
• Provide Implant Card along with the device.
• Improved Product Safety and Post-Market Surveillance requirements.
• Establishment of a Quality Management System based on ISO 13485 QMS, 2016.
• Introduction of 15 new elements to current technical documentation (Annex II + III)

Which type of companies are impacted by EU MDR?

A broad range of company types are impacted by EU MDR. Listed below are the key types, which needs to assess their organization for impact and new compliance level:
• All device manufacturers – devices include instruments, implants, software, materials, reagents, etc. that are used for medical purposes
• Importer and distributors of devices
• Pharma companies with drug-device combined products
• Digital therapeutic producers developing software used for medical purposes
• Some cosmetic and esthetic device product producers

 

EU MDR requirements will specifically impact the below enterprise functions

• Regulatory Affairs (RA): Reclassification of medical devices will need to be monitored by RA. In addition, RA function will be partly orchestrating the correct implementation of data collection and retention throughout the supply chain, in order for RA to receive the relevant data to be submitted to health authorities. Data for submission includes UDI data and additional data found in technical documentation and specifications.

• Supply Chain and Corporate IT: EU MDR will strengthen the controls around traceability and transparency to ensure higher and structured retention of data (UDI) throughout the supply chain. Consequently, some manufacturing processes will require changes, i.e. changes in supplier agreements, investigation of the supply chain will increase, and the exchange and disclosure of data across the supply chain will change. Additionally UDI needs to be generated electronically for each device production batch and marked on the device physically.

• Pharmacovigilance: Medical device manufacturers will need to implement a post-market surveillance plan (PMS) with stricter controls. In some cases, the PMS will need to include a Post market clinical follow-up to facilitate the gathering of quality, performance, and safety data throughout the device lifetime.

• Quality and Compliance: Establishing and maintaining a Quality Management System (QMS) and a Risk Management System (RMS) throughout the device life cycle is a requirement from the new EU MDR. Differently from the past, QMS will need to be compliant with ISO 13485 QMS of April 2016, and RMS with ISO 14971.

 

NNIT takes you through an EU MDR readiness assessment to identify the gaps and then implement the changes needed to be compliant:

NNIT has a long term experience with conducting new regulatory impact assessments and following implementation of gap closure activities. Previously, NNIT has supported life science companies in compliance of ISO IDMP, EMA SPOR requirements, serialization, EU GDPR data privacy regulations, as well as GVP and safety regulations.

As a start a EU MDR readiness assessment needs to be conducted for discovering EU MDR gaps found around the life science organization. For this  NNIT’s EU MDR Assessment Tool – DRIVE can be used. DRIVE can assess 250+ new requirements including location of gap and gap severity level.

During the assessment NNIT helps your company scoping your medical devices, and then identify the gap areas where changes are needed to be in compliance with EU MDR.


After the EU MDR Readiness Assessment, DRIVE will output a report containing an overview of gap areas, such as:

• Gaps related to data traceability and transparency and related to UDI requirements
• Gaps in technical documentation for the authorities
• Gaps in Quality Management and QMS
• Gaps related to Risk management
• Overview of organizational impact and heat map

Included in the report, NNIT provides organizations with a strategy and high level road map to close the gaps identified in the assessment.

 

 

 

Niels Buch Leander +45 3075 5339nbln@nnit.comManaging Consultanthttps://www.linkedin.com/in/nielsbuchleanderNiels Buch Leander

 

 

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