Euromcontact RA focus group
Paris, 24 January 2013
SYFFOC Offices – Paris
Draft Minutes – J P Comments
M. Newman – Coopervision (Chair), John Parker – ACLM, EFCLIN, NAC, Ralf Finke – ALCON, Martine Magnant – SYFFOC, Mai Lee Mishir – J&J Visioncare, Abbas Bohra – AMO.ABBOTT, Chloe Mayo – Bausch & Lomb, Catherine Bonnevalle – Menicon, Anne-Marie Wolters – Euromcontact.
Apologies: Hilde Viroux - ALCON
- Opening of the meeting, roll call of participants, introduction of new participants
The group welcomed the new representatives of J&J Visioncare (M L Mishir) and AMO. ABBOTT (A. Bohra).
- Approval of the draft agenda
The agenda was approved.
- Approval of the minutes of last meeting, open action items
The minutes were approved.
Add R. Finke in the participants on the phone.
Continuous wear: J&J Visioncare: is not applicable for J&J Visioncare products– but it is applicable if cessation of wear for overnight cleaning/rest is not accepted as ‘discontinuation’ of wear.
MDR Gap analysis: has a more recent/final document been published?
- Priorities for 2013
The group discussed last years’ achievements.
-The MDD revision is still ongoing and will be continued – ENVI (responsible EU committee) workshop on 26th Feb will be attended by Euromcontact.
-Response to members: the group established a procedure to respond when questions come in.
-Notification of new MEDDEV’s: the group should better inform the members. J. Parker suggested publishing information aboutcomplying with the MEDDEV 2.12/2 on Post Market Clinical Follow Up Studies and the justification for not having a PMCFUS Plan.
-Regarding CMC, J. Parker mentioned that Eucomed has initiated a formal procedure against the CMC decision n° 3 for failure to fulfill their obligations under the EU treaty ()– This affects the recent requirement for Product to have a ‘complete’ postal address on the labeling, and other activities ongoing or planned that the CMC might be doing.
Confirmed Priorities for 2013:
- The MDD (MDR) revision is still ongoing and will be monitored
a. Share/communicate results from the gap analysis
b. Discuss key changes and how they will affect members
c. Provide support to the Euromcontact Public Affairs WG
d. Specifically look at impact of UDI (FDA,MDR)
- Communication process for key MEDDEV and guidance document updates
a. Need to summarize the changes/impact
b. Communicate via Euromcontact website?
c. Establish link with original document.
- CMC monitoring
a. Review impact of current proposals
b.Fully understand their “legal” status and the need to implement their recommendations.
- Review and update Clinical Evaluation document and /or other Regulatory support documents.
M. Newman to contact Dr. Port, everyone: alternative source?
- MDD revision
-Status update, feedback from MDEG:
The aim is to have the MDR adopted before the European elections of the Spring 2014. This is supported by the Irish Presidency.
The Council of Europe has already had 4 meetings on the topic, mainly to discuss the scope and the role of NB’s.
In the European Parliament, the rapporteur and shadow-rapporteurs in ENVI have been designated:
-Rapporteur: Dagmar Roth-Behrendt Dagmar
-Shadow rapporteurs: McGuinness Mairead , Kovacheva Nora, Lepage Corinne, Auken Margrete, Rivasi Michèle, Yannakoudakis Marina, Sousa Alda
-MHRA consultation & position on plano lenses:
Euromcontact has sent in its response largely in line with the GOC response and including a statement on UDI inspired by the J&J response to the FDA.
-Judgement of the European Court of Justice: “The third indent of Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, must be interpreted as meaning that the concept of ‘medical device’ covers an object conceived by its manufacturer to be used for human beings for the purpose of investigation of a physiological process only if it is intended for a medical purpose.”So a coloured cosmetic lens is confirmed not to be a device under the MDD, any change will await the revision.
- PIP immediate measures
-Status of NB recommendation and decision: in some countries unannounced audits have already taken place. None of the members have had an unannounced audit but it would appear that these will be prioritizedby NB’s starting with Class III devices.
-UDI: is now at the stage of a Commission inter service consultation, will be adopted by the end of February. It is the result of the work of European UDI WG and aligned with international work in this area. The Commission will provide guidance for those member states planning to adopt their own UDI.
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- Standards (JP)
-Harmonized standards issues: feedback from MDEG: Hilde Viroux to provide information.
-EN ISO 14971 Annex Z changesenforcement: there are no technical changes that effect device manufacturers.
J. Parker circulated the minutes of the November ISO meeting in London to all members. AFNOR has published the French cytotoxicity standard as a French Standard, but it is highly unlikely that it will become an ISO standard.France is trying to get it adopted as a European Standard (EN), but other European countries should be able to prevent this.
- Fluorescein strips (AMW)
During the B&C meeting of October 2012, it was suggested to have two classifications, one for the therapeutic fluorescein which would be a pharmaceutical, and one for fluorescein to be used with contact lenses, which would be classified as a medical device. All the CA’s were asked to send in their comments. The topic will be discussed at the next meeting on February 18.
- CMC status:
It will be of interest to see how the Eucomed complaint evolves.
- Public Affairs update (AMW)
Both J&J and Novartis are in the process of setting up appointments with health attachés and the rapporteurs to make sure that the draft text related to cosmetic plano lenses (classification as a medical device) stays in the text as is. AMW will invite both lobbyists to the next meeting of the RAFG in Brussels to stay informed about their work.
- Clinical evaluation document:
-a. Update:The group agreed that an update was needed. MN will contact Dr. Port and another possible author and ask for a quote by April 11 (Euromcontact GA decides about the 2013 budget). Dr. Port will also be asked to include a chapter about the method and how it complies with MEDDEV 2.7.1 (RF to provide the basic list of questions he received).
-b. What to do with requests from own brand labelers and authorities outside the EU?
The RAWG is comfortable with the document being used for this purpose.
- AOB
-Confirmation of dates/locations for 2013 meetings: 16/4 in Brussels (10.30-15.30), 20/6 in Paris starting at 10 a.m.- 14.30 p.m.) , 3/9 ? tbc at the April meeting in Brussels (10.30 – 15.30).
-Support documents for smaller companies: any ideas and who could do it? JP will promote the existing documents(Clinical Evaluation and Risk Assessment) again at the EFCLIN congress and ask whether there would be an interest for MDR-related guidance on drawing up a STED (Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety & Performance of Medical Devices)Has anyone actually been asked for one by their NB? Decision to be taken at the June meeting.