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Are you ready for the Medical Device Regulations?

The Facts:

  1. Nearly 4 times more words than the MDD
  2. 5 more annexes than the MDD
  3. The word “safety” is used 290 times, and 40 times in the MDD
  4. More text = more work
  5. Notified bodies (NBs) = finite resource, with several NBs threatening to withdraw their services
  6. Skilled resource to make transition = finite resource
  7. Resources will create a bottleneck creating a first come first served scenario for Notified bodies to maintain CE mark to MDR and getting new products to market

Strategy:

  1. Top Management need to pay attention
  2. Identify the new requirements of the MDR/IVDR versus the MDD and the IVDD
    Prioritise portfolio looking at business impact (revenue/profit) and work required to maintain product CE mark
  3. Remediate technical files to align with new standards
    Submit application for MDR/ IVDR certification with notified body

Fail to do the above soon, and:

  1. You will struggle to meet the transition timeline by 2020
  2. Consequently be unable to continue selling your product in the EU market without being re-certified to the new regulations
  3. Consequently be unable to launch a new product in the EU market without being certified to the new regulations
  4. If the EU market is your only market, you will not have a product to sell

The new regulations became effective in May 2017 for the MDR – 2017/745 and is on a strict timeline.

Medical Device Regulations Timeline

However, this timeline is deluding as there are the following assumptions –

  1. Notified Bodies will be able to turn around your application in the same timeframe as the the MDD and IVD
  2. Your transition will be straight forward
  3. You will have resource to fix the wrongs and close the gaps quickly

This may come as a shock to the industry as neither of the above assumptions should be made and taken lightly as this could cost you heavily. The new regulations have much more demanding requirements than before, namely –

  • Clinical Evaluations are more stringent
  • Classifications may have changed due to new rules changing the risk of your device
  • You may have new products that are now classed as devices which were not before
  • Software Validation requirements are more stringent
  • UDI additions
  • Post Market requirements have increased with PSURs

What to do next –

  1. Contact me on 07752 144409 or info@pharmi-med.com for a private and confidential conversation about your requirements
Medical Device Regulations Flowchart

Pharmi Med Training courses and templates will keep you on track together with our consultants who are ready to keep you in the market!

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