Proposed EU MDD (Medical Device Directive) Revision(s) - 2012 - 2013

[Mondo 22]

All,

The MDD is being revisied again.

What are the main proposed changes?

Thanks,
Ray

[paulag]

While industry may be relieved to find that the European Commission's proposed changes for the regulation of medical devices do not support the concept of pre-market authorisation, they include a proposal for a "scrutiny mechanism" for high-risk devices/IVDs, as well as giving the commission more power to play a heavier hand than ever before in the regulation of medical devices and IVDs.
One particularly radical measure is that the notification of all notified bodies under the current medical device and active implantable directives will be void as of three years after the new medical devices Regulation first takes effect. Notification of all notified bodies under the current IVD directive will be void as of five years after the IVD Regulation takes effect. That is, if the European Parliament and Council agree to the commission's proposals.
And when it comes to new requirements for notified bodies, these will apply from six months after the Regulation enters into force for those notified bodies who reapply for notification under the current rules.
Other proposed measures include the possibility to make a single clinical trial submission to the Eudamed database even though the trials are carried out across several EU member states; enforcing manufacturers to appoint a "qualified" in-house regulatory compliance person; and the introduction of fees to register medical devices on the central database, among other things.

[Chrisx]

There are so many changes, that it is hard to summarize them. The largest number of changes are directed towards the notified bodies and not towards manufacturers. This is not surprising, since the role of the notified bodies has for long time been in question. It also depends upon what your organization makes. Here is what I believe will be the major changes for manufacturers:

- Unique Device Identification
- Additional emphasis on clinical data, clinical investigations, and post market clinical follow-up
- Changes in device classification. Spinal implants and aphaeresis devices/accessories are proposed to be class III
- Reprocessors of SUDs become legal manufacturers
- Additional regulatory body to review certain class III devices.
- Creation of test laboratories to test devices as part of regulatory assessment
- Identification of certain cosmetic devices as medical devices despite not fitting the defintion (liposuction, laser treatments, cosmetic contact lenses, implants for body modification)

[pkost]

do not forget the inclusion of distributor, importer and economic operator in the definitions and the obligations they will be placed under (essentially to ensure that the any device they purchase is adequately CE marked and to enable the communcation of complaints)

edit: oh and it's not really a revision.

It's being changed from a directive to a regulation

[Cheeky on tour]

Hi, I'm trying to learn more about the regulatory side, but finding it to be a best kept secret,
I've just read the MDD. Where will I find a copy of the new version and what number will it be given? When is it expected to be officially released?

[Ronen E]

In Reply to Parent Post by Cheeky on tour

Hi, I'm trying to learn more about the regulatory side, but finding it to be a best kept secret,
I've just read the MDD. Where will I find a copy of the new version and what number will it be given? When is it expected to be officially released?

Not a secret at all:

http://ec.europa.eu/health/medical-d...ents/revision/

It will not be 'a new version of the MDD"; it's a totally new instrument (a regulation, not a Directive).

It's going to take a while before it comes into final shape and is implemented.

You could follow this extremely-informative blog, which discusses the process and the implications a lot: http://medicaldeviceslegal.com/
(I'm not affiliated, just a reader).

Cheers,
Ronen.

[wrodnigg]

At the moment everything around the recast of the directive is on hold.

The latest draft of the recast was rejected last year, so we need e re-start.

We have elections for the European Parliament in May 2014 and before that date, nothing will change/move/whatsoever.

After that date, the Commission will write a new proposal...


(Maybe there will be changes for the Notified Bodies in the meantime, but everything is currently inn the flow...)

[pkost]

I'm not sure where you are getting this information from - what do you mean the recast was rejected last year?

The parliaments Committee on the Environment, Public Health and Food Safety issued their draft response to the proposal early April (http://www.europarl.europa.eu/sides/..._source=feedly)... things seem to be progressing with it

Also the MHRA held a public consultation with the response issued on 3rd April

It all seems to be progressing as expected....certainly not on hold