Category Archives: News

IMDRF Draft Guidance on Essential Principles for Medical Devices

On January 18, 2018 IMDRF published GRRP WG(PD1)/N47 Essential Principles of Safety and Performance of 19 Medical Devices and IVD Medical Devices.

The IMDRF Good Regulatory Review Practices group published the draft guidance as part of an IMDRF consultation.

The document’s intention is to help harmonize documentation and procedures to assess whether a medical device conforms to the regulations that apply in each jurisdiction.

The document’s content is:

  • 1.0 Scope
  • 2.0 References
  • 3.0 Definitions
  • 4.0 Safety and Performance of Medical Devices – General Principles
  • 5.0 Essential Principles Applicable to all Medical Devices and IVD Medical Devices
  • 6.0 Essential Principles Applicable to Medical Devices other than IVD Medical Devices
  • 7.0 Essential Principles Applicable to IVD Medical Devices
  • Annex A: Use of Standards in Meeting Essential Principles
  • Annex B: Guidance on Essential Principles

Download the document at

EU-MDR and IVDR Roadmap Published

The Competent Authorities for Medical Devices, CAMD, Implementation Taskforce published the Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap. You can download the roadmap from

The contents include:

  • Clinical Evaluation & Clinical Investigation (MD)
  • Performance Evaluation & Performance Studies (IVD)
  • Scope & Classification
  • Notified Bodies & Conformity Assessment
  • Post-Market Surveillance & Vigilance for both MD and IVD
  • Eudamed & UDI
  • Market Surveillance
  • IVD-specific Issues
  • Over-arching & Cross-cutting Priorities

In addition, there are two documents that include frequently asked questions.

For the EU-MDR, go to

For the EU-IVDR go to

Medical Device Servicing Report Issued

The Food and Drug Administration Reauthorization Act of 2017 (FDARA), Section 710 requires FDA to report on the continued quality, safety, and effectiveness of medical device servicing. In this case, servicing includes refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.

On May 18, 2018, FDA issued Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.

The report concludes that available objective evidence is not sufficient to support a widespread public health concern related to servicing of medical devices that would justify imposing additional/different burdensome regulatory requirements. FDA intends to pursue the following actions:

  1. Promote the Adoption of Quality Management Principles;
  2. Clarify the Difference Between Servicing and Remanufacturing;
  3. Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices; and
  4. Foster Evidence Development to Assess the Quality, Safety, and Effectiveness of Medical Devices

MDR Adverse Event Code Harmonization

On April 6, 2018, FDA updated codes for MDR reporting. The updated code hierarchies are: Device Problem Code, Manufacturer Evaluation Method Code, Manufacturer Evaluation Result Code, and Manufacturer Evaluation Conclusion Code.

The update harmonizes the codes with the IMDRF Adverse Event Reporting Terminologies. The FDA codes correspond to IMDRF Annexes A through D, available from

FDA plans to harmonize all remaining FDA adverse event codes with the IMDRF codes as they become available.

The eMDR system rejects retired codes.

FDA has updated eSubmitter for the new codes.

CEN/TR 17223:2018 Issued

A new technical report from CEN is an invaluable tool for EU-MDR and EU-MDR implementation. It provides a cross reference between the requirements of the new regulations and the clauses of ISO 13481:2016. The technical report has two extensive tables, one for each regulation. The tables start with the specific requirements in the articles, follows them through the annexes, identifies the applicable clauses of ISO 13485:2016, and offers a conclusion on the coverage.

CEN/TR 17223:2018 Guidance on The Relationship Between EN ISO 13485:2016 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

UDI Direct Marking Final Guidance

On November 17, 2017 FDA-CDRH issued the final guidance document on Unique Device Identification direct marking. The final guidance replaces a draft issued on June 26, 2015.

The UDI final rule created the system of direct marking. The final guidance provides additional details for the rules implementation. In particular, the guidance document provides definitions of some terms that apply to UDI direct marking including “intended to be used more than once” and “intended to be reprocessed”.

Additive Manufactured Devices Final Guidance

On December 5, 2017, FDA-CDRH issued a final guidance document on additive manufacturing replacing the May 10, 2016 draft version.

The final guidance document, Technical Considerations for Additive Manufactured Devices (UCM499809) outlines technical considerations associated with additive manufacturing processes, and recommendations for testing and characterization for devices that include at least one additively manufactured component or additively fabricated step.

The final guidance document includes two topic areas: Design and Manufacturing Considerations (Section V) and Device Testing Considerations (Section VI).

  • The Design and Manufacturing Considerations section provides technical considerations that should be addressed as part of fulfilling Quality System (QS) requirements for your device, as determined by the regulatory classification of your device and/or regulation to which your device is subject, if applicable.
  • The Device Testing Consideration section describes the type of information that should be provided in premarket notification submissions (510(k)), premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo requests and investigational device exemption (IDE) applications for an additive manufacturing device.

ISO/IEC 17025:2017 Published

ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories replaces the 2005 version.

The more significant changes include:

  • A revised scope to cover all laboratory activities including testing, calibration, and their associated sampling
  • A new structure that matches other conformity assessment standards
  • A process approach that matches newer standards such as ISO 9001:2015
  • A stronger focus on information technology that recognizes that hard copy documents are being phased out
  • A new section risk-based thinking
  • Updated terminology

The new version was published at the end of November 2017. The International Accreditation Service, IAS, published a transition timeline that says all labs must conform to the new standard by Dec. 1, 2020.

eSubmitter Version 3 Available

FDA has released eSubmitter Version 3. This software allows the user to create reposts, such as MRD or Corrections & Removals, and format them for transmission to FDA Electronic Gateway.

The plan is to allow use of eSubmitter Version 2 until May 2018, when it will be disabled.

Ombu recommends immediate update to Version 3 to ensure all the manufacturers’ internal processes are updated and working before the end of Version 2.