I. CE MDD (European Medical Device Certificaiton Procedure)

Medical device(hereinafter, CE MDD) certification in European counties is getting more and more difficult since 2013.

The European Commission has begun applying fourth amendment of Guideline for Clinical Evaluation (MEDDEV 2.7/1 Rev. 4) from June 2016, and another word for European medical device certification is clinical evaluation.

What changes has been made?

No much, but so much.

Overall procedures and contents of the new clinical evlauation guideline are similar to the previous one. However, requirements and exampels are now described in great detail. This means, if you are familiar with previous clinical evluation, you won’t have much trouble adapting into revision 4. Hoever, you are likely to spend much more time to prepare the contents of the clinical evaluation. Because so many things are clearified.

One of the most import requirement which is specified in revision 4 is the requirements for demonstration of equivalence.

You have three choices

  1. Generate clinical data through clinical investigation of the device under evaluation
  2. Draw on the clinical experience and literature reports of the safety and performance of an equivalent device to establish the clinical evidence.; Or
  3. Use compliance with harmonised standards to satisfy the clinical evidence requirements for the devices

There’s not much change with clinical evaluation route 1. You won’t need to demonstrate equivalence of your device to any others. However, to use 2 and 3, you will need to do some extra works that you might not have done previously.

Route 2, the guideline revision 4 requires you to demonstrateie equivalence in clinical, technical and biological perspectives. Basically, you will need data of raw materials of the device you have chosen to demonstrate equivalence with.Choosing rounte 3 won’t make it much easier. It order to use route 3, you will need to demonstrate safety and performance of your device based on very well established qualitative and quantitative data. This route could be useful to clinical evluation of devices with long history and low risks.

II. ISO 13485: 2016, Medical devices — Quality management systems — Requirements for regulatory purposes

New vsersion of Quality Management System Standards for medical device organization, ISO 13485: 2016 has published. ISO 13485: 2003 and/or 2013/Cor1:2008 are no longer valid since March 2016. Though the standard has not been harmonized, yet(Jan, 2017), Some of the Notified Bodies already issued transition policy.

Major changes are as below.

  • ISO 13485 is no longer in line with ISO 9001.
  • New requirements added regarding regulatory requirements, competency, design controls, purchasing controls, and software validation.

The Year of Uncertainty
In addition to changes which already have taken place and changes which are planned to come, product certification and approval of developed countries with large consumer market will become more and more difficult to protect domestic industry and job positions.
Everybody from all over the world have heard the news saying “the year of uncertainty”

Companies which export take large portion of sales shall consistently monitor their major exporting country(ies) to cope with changes in regulatory requirements. A quick and precise response will prevent crisis.

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