Manufacturers of Reusable Surgical Instruments: BSI Launches Urgent Appeal : submission of applications regarding TF for 1R MD to be received within November 01, 2019
Dear Partners and Manufacturers of 1 R MD more particularly,
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Last late August 23rd, the British Standards Institution (BSI) issued an urgent appeal to manufacturers of class I reusable surgical instruments:
You certainly knew that, according to Directive 93/42 / EEC, these devices could be placed on the market (…)
Most recent articles
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Manufacturers of Reusable Surgical Instruments: BSI Launches Urgent Appeal
2 September 2019, by MME -
August 21st Update - NANDO and MDR Notified bodies
20 August 2019, by MMEAugust 21st 2019 - Latest news from NANDO concerning future "MDR-NB".
Dear Partners,
We’ve just learned this morning that, August 20th, NANDO had designated a fourth Notified Body
Here is the link to European commission NANDO :
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
However, all NBs may not be designated neither for all (classes of) devices though, (for instance Class III or implantables), so don’t hesite to (…) -
Additional guidance released _ Vigilance
18 August 2019, by MMEVigilance reporting : Latest release to provide further guidance to the use of new MEDDEV forms to be used no later than Jan 01, 2020
Dear Partners and Vigilance teams members,
The EU commission recently released, early days of August 2019, Additional Guidance Regarding the Vigilance System : MEDDEV 2.12-1 rev 8 here attached.
This document provides additional guidance in relation the Vigilance System of reporting which will be compulsory used starting January 01, 2020 (even if (…) -
July 2019 - More about NBs
15 July 2019, by MME2019-07-15 - More about Notified Bodies out or in the run for MD/IVDR...
2019-07-15 - More about Notified “Bodies”
• Austria: lost all its ONs last year, but a new one has been created, Quality Medical Devices (QMD), being notified for MDR, the IVDR to follow
• Spain: AEMPS (NB0318) , a single Spanish ON, filed its MDR case
• United Kingdom:
UL International (UK) Ltd. (NB 0843) announced the termination of its ON MDR activities. They will continue under a unique (…) -
2019-07-11 Updated EU Vigilance general guidelines
11 July 2019, by MMEAdditional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
Dear Partners, Our previous publishing of the 2018 FSCA forms (FSN - general ; FSN forms for Distributors (as with FDA) ; FSN forms dedicated especially to End Users (wether professional or totally "Profane" users) might have already come to your attention ;
As well as our publishing concerning the two revised forms for MIR (Manufacturer Incident Report) ; 1/ one kind of "hybrid" revision being (…) -
About SRN request by Notified Bodies
10 July 2019, by MME2019-07-10 _ About SRN request by Notified Bodies
Dear Partners,
You may already have been confronted and still might be confronted to a question asked by your Notified Bodies about mentioning SRN (Single Registration Number) on their application forms, could the SRN required be yours - as Manufacturers- , or ours - as your EAR.
It had started with Class 3 devices application forms and since been enlarged to all other products.
But of course, SRN are not available right now, as (…) -
Guidance about PPRC
1 July 2019, by MMEGuidance on Article 15 - MDR_IVDR PPRC
Person Responsible for Regulatory Compliance
Dear Partners,
Please find here attached a guidance recently released by MDCG about the definition and role of a "Person Responsible for Regulatory Compliance" such as defined in Article 15 of MDR / IVDR 2017/745 and 745.
With our best regards,
Christine and René -
About MDR NBs and others
22 June 2019, by MMEAbout NBs
TÜV Süd becomes second Notified Body designated to European MDR by NANDO.
At the same time, LQRA company announced it will no longer support CE Mark certification services under the current Medical Devices Directive (MDD) or In-Vitro Diagnostic Medical Device Directive (IVDD), and will not seek designation under the upcoming Medical Devices Directive (MDR) or In-Vitro Diagnostic Devices Regulation (IVDR).
LRQA’s withdrawal of NB services is expected to be effective by (…) -
Brexit _ UKCA marking April 01, 2019 Update
1 April 2019, by MMEUsing the UKCA marking if the UK leaves the EU without a deal.
GOV-UK - April 01, 2019 publishing
Background Breaking News
• 29 March: House of Commons rejected Brexit divorce deal for third time (344 votes to 286 against, a majority of 58). • 1 April: House of Commons rejects all Brexit options — again.
_ The result of the second round of so-called indicative votes means that with just 10 days until Brexit day (April 12nd) the country still has no plan to (…) -
BREXIT ISSUES - 2019-03-19 MHRA last update _ vs EU Com release dated Feb 01st
19 March 2019, by MMEMHRA March 19th 2019 Update about Brexit Issues confronted to EU Com last release about (how to manage) Brexit issues.
Complementary points of views, even if some zones of confusion still exist due to the general historical and even more to the current context, as you may guess.
Dear Members and Partners,
Please find here attached under pdf format the last information published last March 19th, 2019 on MHRA website as guidance to manage Brexit issues.
Hoping guidance updates will (…)