Revised Medical Devices Directive
The European Medical Devices Directive 93/42/EEC has finally been revised and emerged from the EU process as 2007/47/EC. MeddiQuest's Neil R. Armstrong gives an overview of the changes.
The Revision Process
The original directive was drafted with a clear vision in the heady days of the dawn of the New Approach. However, the vision seems to have slipped and, as so often is the case, Europe has reverted to a belief in the superiority old fashioned detailed regulation. We had great hopes that in this, long overdue, first revision of the medical devices directive we would see a return to the vision and clarity of the original - our hopes were dashed! What we have is a fudge that addresses some of the easier more obvious issues but shies away from the difficult questions, alas the seems to be a necessity in gaining acceptance in a larger more diverse Europe.
Commentary on the Changes
Leaving aside our disappointment at the final outcome from such a protracted process, let's look at the changes. There are numerous minor revisions to the text - these will impact everyone in the medical technologies industry. Even if none of the change actually affect your product, you will need to show that, for example you have assessed your product against the new Essential Requirements, but for manufacturers of certain products the changes may dramatically alter their regulatory regime.
Many of the changes are not really changes at all, there are simply clarifications, making crystal clear the interpretation that the majority of the industry have made of the regulations.
Summary of the Changes
- Software is a medical device in its own right. Validation is an essential requirements.
- Directions for Use must be revision controlled and include reference to the revision date/issue.
- Clinical Evidence is renamed Clinical Data as is required for all devices - this need to be in line with a substantially amended Annex X.
- Records must be maintained for the longer of the useful life of the product, or, 5 years from the date of manufacture. For implantable devices the minimum time is 15 not 5 years.
- Class I Sterile and Measuring devices may now choose the full Quality Assurance Conformity Assessment Route, Annex II.
- The rise of the virtual manufacturer is recognized in additional monitoring requirements for outsourced design, manufacture and other activities.
- Notified Bodies are required to inspect design documentation more closely and use accepted statistical techniques based on a risk assessment.
- The EU Authorized Representative gets a mandate to act for the manufacturer.
- Personal Protective Equipment is now subject to the general PPE directive 89/686/EEC as well as the Medical Devices Directive
- Post Market Surveillance and reporting requirements apply to Custom Devices.
- A process for determining whether borderline products are medicines or medical devices is defined based on primary mode of action (rather than intended use).
- European Databank ... remember this ... clinical Information, Registration, Authorized Representatives, Certificates and Vigilance will now be included ... well that is if we ever get the databank of course! The new target is September 2012. 5 years does not sound too ambitious for an "off-the-shelf" database, but with our experience of EU computer projects, we do not recommend holding your breath!
- Continuous Use has been redefined away from a single product, so that even if a product has to be routinely replaced the total period of use is considered continuous use.
- The definition of central circulatory system has been expanded to includes arcus aortae and aorta descendens to the abifurcatio aortae.
- Devices using human tissue, blood or plasma are class III and subejct to 2001/83/EC.
Because there are so many changes to the text of the directive we advise every manufacturer to download the full text and read it carefully considering application to their products. You can download a copy direct from the Europa/Eur-Lex website by following this link .
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Uploaded October 19, 2007
Last updated October 19, 2007
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