1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
  2. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Revision of the MDD

Discussion in 'EU Medical Device Regulations' started by JCIC49, Aug 17, 2015.

  1. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    Has anyone reviewed the changes following the release by the European Council in June?

    Also does anyone have any idea on the timescale for the final document being released?
     
  2. Pads38

    Pads38 Member

    Joined:
    Aug 6, 2015
    Messages:
    28
    Likes Received:
    22
    Trophy Points:
    2
    Location:
    UK
    I have not, myself, reviewed the changes but have been keeping track of things by monitoring the Medical Legal blog of Erik Vollebregt (who was also on the Cove). From that blog:-
    That post can be found here:-
    http://medicaldeviceslegal.com/2015...medical-devices-and-ivd-regulation-proposals/
     
  3. Steve Kent

    Steve Kent Member

    Joined:
    Aug 3, 2015
    Messages:
    25
    Likes Received:
    25
    Trophy Points:
    12
    Location:
    UK
    Not bedtime reading - 202 and 170 pages for the draft Regs. and Annexes respectively. I've concentrated on the what were the Essential Requirements, now GENERAL SAFETY AND PERFORMANCE REQUIREMENTS. I've put a draft template checklist together based on the current draft Annex I, but not actually filled them out for my Technical Files yet - no real point. Just did it as an exercise before my brain melted! I also use Erik's blog to keep up to date as Pads indicates. I also found this at another source but have lost the link:

    "Note that the proposed change to the Medical Device Directive (MDD) to become MD Regulations continues to get more complicated due to issues raised by various EU players. The final EU Council session on the MDR & IVDR under the Latvian presidency in late June saw the release of the two draft proposals plus annexes. These conveyed the Council’s partial general approach. In any event, given the areas where trialogue agreement is already looking potentially hard to secure, agreement on the MDR by the end of 2015, under the Luxembourg presidency, is unreasonable to assume, Council sources believe. Agreement under the Dutch presidency (January-June 2016) is “possible”, however."

    Steve
     
  4. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    Thanks Steve, I agree not bedtime reading unless you find it difficult to sleep. I am slowly working my way through it. I am not making any updates to any documents based on it until we are sure of the final draft and transition period. I am just making people aware of the potential changes and the implications of this.

    Once I have time to put a comparison document together between the MDD and the new MDR I will look to post it here, but don't hold your breath waiting for it.
     
  5. wcraycroft

    wcraycroft New Member

    Joined:
    Aug 17, 2015
    Messages:
    4
    Likes Received:
    0
    Trophy Points:
    1
    Hi Steve,
    Where can I get this bedtime reading? The latest full proposal text that I can find on the EC site is the "26.9.2012, Proposal for a REGULATION ...on medical devices ...". It is 194 pages. You seem to be referring to a different doc. Also, could you share the "draft template checklist" you created? It is exactly what I was about to do for an implant. Thanks for any help you can give.
    Best Regards,
    Warren
     
  6. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    Hi Warren,

    I have attached the details published in June this year

    Regards

    Jon (JCIC49)
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

    QAengineer13 and Ronen E like this.
  7. Steve Kent

    Steve Kent Member

    Joined:
    Aug 3, 2015
    Messages:
    25
    Likes Received:
    25
    Trophy Points:
    12
    Location:
    UK
    Hi Warren,

    There were further updates in July - attached. As to my links to these I have forgotten for the time being - its my age I guess (further brain melt)! I will post my checklist when I've tidied it up a bit.

    Steve
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

    JCIC49 likes this.
  8. Steve Kent

    Steve Kent Member

    Joined:
    Aug 3, 2015
    Messages:
    25
    Likes Received:
    25
    Trophy Points:
    12
    Location:
    UK
    JCIC49 likes this.
  9. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    Hi Steve,

    Thanks for the latest copy I need to add this to my review.

    One thing that I think people need to be aware of is the proposed changes to the vigilance reporting time lines as detailed in Section 1 vigilance starting at article 61. The reporting has changed from 30 days to 15 days of becoming aware as a maximum but this time scale is dependant upon how serious the event is.

    Throughout the whole document there are changes like this, but the big problem is that until we have the final published document it is difficult to determine what will actually be required.

    There are areas that from my own recent experience that the Notified Bodies are focussing on. These are mainly around supplier control, i.e. do you as a company placing a device on the market have a full understanding of your whole supply chain and do you have the relevant controls in place with all your key subcontractors.

    As I said once I have completed a review and if it is possible to document it I will. From first view it is not easy to do a complete Gap analysis between the MDD and the new regulations, but it is possible on individual sections such as Annex I.

    Jon
     
    Jim Hagenbaugh and Ronen E like this.
  10. Steve Kent

    Steve Kent Member

    Joined:
    Aug 3, 2015
    Messages:
    25
    Likes Received:
    25
    Trophy Points:
    12
    Location:
    UK
    Hi Jon,
    Interesting feedback on the NB take on suppliers.
    For Warren I have attached the checklist. This is based on the most recent Annex I and I have retained its italics and highlights. Obviously this can change again in the future. Also I cannot guarantee that I have not made the odd typo etc!
    Steve
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

    Jon Cook, DaveH, rob73@work and 2 others like this.
  11. QAengineer13

    QAengineer13 Member

    Joined:
    Aug 3, 2015
    Messages:
    47
    Likes Received:
    13
    Trophy Points:
    7
    Hi Steve/ Jon,

    Thanks for all the inputs you are providing to the forum related to the proposed EU regulations , much appreciated!

    Cheers.
     
  12. Yasuaki

    Yasuaki New Member

    Joined:
    Sep 17, 2015
    Messages:
    1
    Likes Received:
    3
    Trophy Points:
    2
    Last edited by a moderator: Oct 11, 2015
  13. wcraycroft

    wcraycroft New Member

    Joined:
    Aug 17, 2015
    Messages:
    4
    Likes Received:
    0
    Trophy Points:
    1
    Hi Steve,
    A belated thanks for the draft checklist and links to the draft directives. I appreciate your help.

    When the new directives are published in the Official Journal, will there be a grandfathering period for a new submission? I understand the grandfathering for existing devices, but I will be submitting sometime next year, possibly just after the new directives are published. I heard that any new CE Mark submission made after the directives become law must be done under the new directives only. True?

    Best Regards,
    Warren
     
  14. Ronen E

    Ronen E Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    133
    Likes Received:
    70
    Trophy Points:
    27
    Hi Warren,

    1. First, the new framework will consist of regulations, not directives. This is significant. Regulations apply directly in all Member States. Directives need to be transposed into State law.

    2. We don't yet know for sure what the new regulations will say. At the moment they are just proposals, and can change significantly before being finalised / published in the OJ.

    3. Typically, there are transition provisions. This means that the new legislation is fully binding only X time after it's been published (sometime there's a gradual entrance into force, with different parts commencing at different times). This is all detailed in the new legislation. If you're interested in what the current proposals are saying about it, search for the term "transition".

    4. Your application should be handled according to the legal provisions that are in effect by the time you make it (in line with the transition provisions). It might be possible that you'll apply after the publication but within the transition period, in which case your application will initially be subject to the older legislation (e.g. 93/42/EEC).

    Cheers,
    Ronen.
     
    Last edited: Oct 11, 2015
  15. wcraycroft

    wcraycroft New Member

    Joined:
    Aug 17, 2015
    Messages:
    4
    Likes Received:
    0
    Trophy Points:
    1
    Thanks, Ronen

    I’m studying Article 97 “Entry into force and date of application” in the 17 July 2015 draft of the Proposal for a Regulation. Do I have the following right?

    1. “This Regulation shall enter into force on the twentieth day after its publication in the Official Journal”. Let’s make an example that the entry-into-force date is July 1, 2016.

    2. “It shall apply from [three years after entry into force]. The date of application in my example would be July 1, 2019.

    3. Paragraph 3 lists the exceptions where certain articles are applied earlier or later than the date of application. For example, Article 24a, UDI for implants, applies one year after date of application, or July 1, 2020 in my example. And Articles 28 to 40 affecting Notified Bodies shall apply six months after entry into force, or Jan 1, 2017.
    If my implantable device is ready to submit to a Notified Body on October 1, 2016, then the current Directive 90/385/EEC would still apply. None of the new regulation would apply, assuming an entry into force date of July 1, 2016 and assuming that the current draft text of Article 97 is not materially modified before the regulation is published.

    Would someone check my thinking here? Are my assumptions correct?

    Thanks,

    Warren
     
  16. Ronen E

    Ronen E Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    133
    Likes Received:
    70
    Trophy Points:
    27
    Hi Warren,

    Too many "if..."s. What-applies-when depends on not-a-few clauses in more than 1 article, and any number of them might still change. Even if they didn't, answering your query would require a careful analysis of the applicable clauses against your device - the kind of analysis you probably carried out before posting... It's not a 5-minute job, and access to the relevant details is required.

    I intentionally avoid studying the new regulation in great detail right now, because as a spectator of the legislative process so far I am quite skeptical with regards to the draft staying essentially unchanged between now and its OJ publication. Quite the contrary. Once it's finalised, I expect many hours of pure bedtime-reading joy...

    As a general notion, there would be a generous transition period so that manufacturers could pick up the final text when it's published and still have plenty of time for an orderly implementation. I don't expect any requirements to be applicable to manufacturers right after publication / coming into force. The old directives are going to be around for a while.

    Cheers,
    Ronen.
     
  17. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
    Hi Warren,

    In looking at the version published on the 21st September 15, there have been changes from the version published on the 17th July, so as Ronen points out be careful about making any changes based on these drafts.

    Yasuaki has included the link to the September 15 version.

    The other aspect you should consider, is even when they are finally published but haven't come into force, the notified body will be expecting you to be taking then into account. So from your example you have given, you are correct on the current directive applying, but I would expect the your Notified Body will want to be thinking and planning for the impact of the new regulation.

    Hope this helps

    Jon
     
  18. wcraycroft

    wcraycroft New Member

    Joined:
    Aug 17, 2015
    Messages:
    4
    Likes Received:
    0
    Trophy Points:
    1
    Thanks, everyone. It's a moving target for a while. Thanks for the links and the search criteria. I can get right to the latest drafts now when they come out (by putting "consolidated text" in the Words in Text field).

    - Warren
     
  19. JCIC49

    JCIC49 Member

    Joined:
    Jul 31, 2015
    Messages:
    42
    Likes Received:
    27
    Trophy Points:
    17
    Location:
    United Kingdom
  20. Xavier Canals-Riera

    Xavier Canals-Riera New Member

    Joined:
    Jan 10, 2016
    Messages:
    3
    Likes Received:
    0
    Trophy Points:
    1

Share This Page