The content below is a highly recommended article about specific information concerning how your QMS and EU-MDR/EU IVDR will impact your organization. This in my opinion is very concise and comprehensive. A great resource for your Quality Team and Executive Management. Tim Cassity CEO Qualmetrica LLC
By Laura Court, March 13, 2022 , in Regulatory Compliance and Medical Device Product and Quality Management System (QMS) and Technical File and EU MDR and EU IVDR
Generally speaking, technical documentation is the compilation of documents that explains how a product is designed, its intended use, and other relevant information. The term itself is used in nearly every industry, and carries extreme importance in highly regulated markets.
In the medical device industry, specifically, technical documentation refers to the documents needed by a manufacturer to prove conformity to regulatory requirements. Also known as a technical file, this documentation functions as a highly detailed, organized, and searchable summary of all included documents.
One market, in particular, places the utmost level of importance on technical documentation for medical devices: the European Union (EU). Technical documentation is a key requirement of the conformity assessment procedures that a medical device must undergo in order to obtain CE Marking to be sold on the EU market.
Let’s review exactly what is expected in this technical documentation so you can understand what you need to do to follow the EU regulations that require it:
TECHNICAL DOCUMENTATION REQUIREMENTS UNDER EU MDR
The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to provide thorough and complete technical documentation for any product sold in Europe. These can be found specifically in Annex II and Annex III of the regulation.
Additionally, MDR guidelines published by the European Commission (EC) have raised the level of detail needed for technical documentation and the related conformity assessment. It also has expanded the manufacturer’s obligations by emphasizing the entire product lifecycle, requiring a post-market phase required for at least 10 years after a product is placed on the market.
However, this guidance has also helped to provide clear instructions as to what specifically is needed for technical documentation as well as what to expect from Notified Bodies (NB) who review these materials during conformity assessment audits.
ANNEX II — TECHNICAL DOCUMENTATION
Annex II of EU MDR outlines the technical documentation and summary requirements that manufacturers must have.
DEVICE DESCRIPTION AND SPECIFICATION
This large section should clearly identify and describe the device and its functionality, intended purpose, and risk classifications, and generally justify why this device exists.
Contents of the device description portion shall include:
· Product Name
· UDI
· Classification
· Intended purpose
· Patient population and medical condition
· Principle of operation
· Overview of previous generations (legacy) of the device
· Overview of similar devices (predicate)
INFORMATION SUPPLIED BY THE MANUFACTURER
This section includes requirements for product labeling and instructions for use. The parameters for these can be found under Chapter III — Requirements Regarding the Information Supplied with the Device (SPR 23) in Annex I of the regulation.
Keep in mind that you’ll need a translation for the local language of the EU country you choose to market in.
DESIGN AND MANUFACTURING INFORMATION
This information related to the design and manufacturing of your device provides context and understanding to key design and manufacturing stages. You’ll need to describe both processes entirely, provide manufacturing validations, evidence of monitoring, and identify suppliers and subcontractors for all materials used.
Because this section can be so extensive and interwoven, it is recommended that you make use of flow charts to clearly show processes and relationships.
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS (GSPR)
The section on General Safety and Performance Requirements identifies all of the activities you must perform for your device type. Previous EU directives refer to this section covering the General Safety and Performance Requirements as Essential Requirements.
BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
This section covers the technical documentation requirements for benefit-risk analysis and risk management that must be followed in accordance with ISO 14971. Essentially, manufacturers need to demonstrate that the benefits of your medical device outweigh the risks associated with it, and that the associated risks have been mitigated as much as possible.
PRODUCT VERIFICATION AND VALIDATION
The MDR places a heavy emphasis on collecting pre-clinical and clinical data during design and development. This section of the regulation covers the documentation requirements for all verification and validation tests, as well as any additional studies to demonstrate device conformity, and covers elements such as test results, test design, methodologies for data analysis, stability, shelf-life, general performance, and safety.
Additionally, your CER (Clinical Evaluation Report) should provide a comprehensive overview of the device’s design and composition, as well as its intended applications and any relevant literature reviews.
ANNEX III — TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE (PMS)
This portion of technical documentation will be used to inform, including post-market surveillance plan, post-market clinical follow-up (PMCF) plan, and periodic safety update report (PSUR). This will also inform future benefit-risk analysis for product updates.
KEEP YOUR TECHNICAL DOCUMENTATION UP-TO-DATE & COMPLIANT WITH EU MEDICAL DEVICE REGULATIONS
With such high expectations for technical documentation, it’s becoming an expectation of regulators for the technical file to live within a manufacturer’s QMS throughout the entire product lifecycle.
Meeting this expectation is nearly impossible when using legacy tools like paper-based quality systems, which require users to manually update and maintain stacks of scattered document files and reports.
The clear winner as far as quality systems go is an eQMS solution like Greenlight Guru that automatically manages your technical file and other documentation.
Our medical device-specific solution makes the entire technical file process seamless and removes the regulatory burden so you can maintain compliance with EU MDR and other industry regulations with ease.
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