• Email
  • Facebook
  • LinkedIn
  • Twitter
  • Vimeo
Contact Us

Manufacturer's Edge

Transforming Colorado One Company at a Time

  • COVID-19 Resources
    • Main COVID page
    • Product & Services Directory
    • Critical Supply List – Manufacturing Specs
    • Cybersecurity
    • Health and Safety in the Workplace
    • Loans & Financial Resources
    • National/International Resources
    • State Resources
    • Supply Chain
  • About Us
    • Staff and Locations
    • Board of Directors
    • Partners
    • Manufacturing Minutes Newsletter
    • Videos
    • Webinars
    • Success Stories
    • Congressional District Fact Sheets
  • Services
    • Cybersecurity
    • Continuous Improvement
    • Technology Acceleration
    • Supplier Development
    • Sustainable Practices
    • Workforce Development
    • Online Programs
  • Events
  • Small Manufacturer’s AdvantEDGE
  • Manufacturers Connect
You are here: Home / Our Services / Supplier Development / MDD Consulting

MDD Consulting

Medical Device Directive or CE Marking for Medical Devices

In order to sell medical devices in Europe, the manufacturer must obtain a CE mark. Basically this means they must prove their device is safe and effective. This is also true of in-vitro medical devices and active implantable medical devices which have their own separate legislative directive, but which basically follow the same rules.

European government recognizes that less risky devices should be able to be demonstrated in a less comprehensive and thus less costly way, versus more risky devices. So like the FDA in the US, they have categorized devices according to that risk, into different medical device classifications. The least risky Class 1 has fewer requirements to address and no audit/review is required. The most risky Class 3 (middle classes are 2a and 2b) has more requirements including comprehensive product master file and design review and independent auditing of management system requirements.

MDD compliance starts with getting certified in ISO 13485. While it is not mandatory in the legislation, it is the accepted solution to the quality management requirements that are in the legislation. If you get ISO 13485, audited by an “approved” certification body (known as a Notified Body) then it is illegal for anyone to challenge you, because you have met this part of the legislation.

Next the legislation requires additional management system controls such as post market surveillance, vigilance and reporting among others. There are also some technical parts of the legislation that it just makes sense to design a process to ensure it is achieved and thus these become part of the management system.

The technical requirements of the legislation require you to put together comprehensive records for your product including clinical and other testing, For instance if your device includes electronics or electrical components then you need testing reports to prove stability for radiated and conducted interference. Risk assessments on the device (and some production processes) are necessary and detailed evidence must be put together to support conformance to the requirements in the legislation (known as the Essential Requirements.) There is an expectation that if international or national standards exist for your product or relevant processes e.g. sterilization, toxicity testing, etc. that these will be followed. You can argue against some standards (after all the legislation didn’t make them mandatory) except those formally “harmonized” which means its impossible to argue.

Finally it is important to note that while say, FDA and CE marking are separate, they both basically demand the same thing. The approach to demonstrating it should be one system, one way of doing things and one set of records (wherever possible). Some separate evidence is necessary (e.g. ISO 13485 versus CFR21 Pt. 820) and sometimes duplication to present it differently to a different agency, but substantially one system.

Consulting

Featured Consulting

Company transformations

Training

Training

Results-driven training

Events

Events

Browse upcoming events

Success Story

Success Story
Improvements and Expansion Helps Propel the “Fairy Godmother of Fire” to New Heights

Tim and Voni Flaherty met while attending law school in Chicago and started a grand adventure that has seen them explore a variety of career opportunities. Having gone from law to banking to general management at Caterpillar, it was while living in San Antonio a few years ago that

Increased Sales
$5M
Retained Sales
$2M
Jobs Saved
16
Jobs Created
27
Read Full Story
Manufacturer's Edge
Manufacturer's Edge
2650 E 40th Ave
Denver, Colorado 80205
info@manufacturersedge.com

Click here to find our staff & locations
Sign Up for Email Updates
For Email Marketing you can trust.

© 2021 · Manufacturer's Edge All Rights Reserved

Phone: 303.592.4087

  • COVID-19 Resources
    ▼
    • Main COVID page
    • Product & Services Directory
    • Critical Supply List – Manufacturing Specs
    • Cybersecurity
    • Health and Safety in the Workplace
    • Loans & Financial Resources
    • National/International Resources
    • State Resources
    • Supply Chain
  • About Us
    ▼
    • Staff and Locations
    • Board of Directors
    • Partners
    • Manufacturing Minutes Newsletter
    • Videos
    • Webinars
    • Success Stories
    • Congressional District Fact Sheets
  • Services
    ▼
    • Cybersecurity
    • Continuous Improvement
    • Technology Acceleration
    • Supplier Development
    • Sustainable Practices
    • Workforce Development
    • Online Programs
  • Events
  • Small Manufacturer’s AdvantEDGE
  • Manufacturers Connect