2019-03-06 - European Commission: CND replaces GMDN for DM nomenclature
The European Commission published on March 4, 2019, a document on the nomenclature of medical devices.
The surprise is that the GMDN ("Global Medical Device Nomenclature") was not finally selected by the European Commission: it is the CND ("Classificazione Nazionale dei Deviceivi medici"), a nomenclature established by the Italy, which will be used for EUDAMED.
European Commission: CND replaces GMDN for DM (…)
Most recent articles
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2019-03-04 EUDAMED code chosen is Italian CDN
7 March 2019, by MME -
2019 FSCA Management and Meddev FSN forms
1 March 2019, by MMEMeddev guidelines and templates for the management of FSCA and recalls in Europe Application : 2019
Dear Members and Partners,
You may find here attached new forms and templates from Meddev guidelines to be used in case you’d have to start and manage a FSCA in Europe.
These forms shall be used starting 2019.
We would like to draw your attention of the fact that FSN designed for Distributors are now clearly to be distinguished from FSN designed for your End Users.
This is why we (…) -
2019 Revision of Manufacturer Incident Report
18 January 2019, by MMEManufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)
Reporting Template Version 7.0 EU Medical Devices Vigilance System Guidelines and Annexes
Dear Members and Partners,
You may find here attached several documents, amongst which the latest 2019 Revision of the MIR ( MANUFACTURER INCIDENT REPORT) following MEDDEV Guidelines.
Attached too are a "help text" provided with the MIR form by MEDDEV; and six annexes that will help understand (…) -
2019-01-04 From GOV UK : Guidance note on the regulation of medical devices if there’s no Brexit deal
7 January 2019, by Rene ClementBREXIT: What will happen after March 29, 2019 in case of no deal ?
Note: For medicines (part 1) and Clinical trials for medicinal products (part 3), see the link at the bottom of this page)
2. Medical Devices
2.1 How medical devices are currently regulated
ln the UK, ail medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive (…) -
Communication Campaign’ of the European Commission – factsheets and infographics supporting IVDR/MDR implementation Posted on 06.12.2018
17 December 2018, by Rene ClementEuropean Commission published a series of factsheets and infographics as part of their ‘Communications Campaign’ on the Medical Device Regulation (EU) 2017/745 (MDR) and In vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).
We expect more documents to be published in the future such as other factsheets for healthcare professionals. -
10 October 2018 - About Brexit and NB, EAR and distributors located in UK
10 October 2018, by MMEFrom :
EUROPEAN COMMISSION RELEASE - Brussels, 22 January 2018 - REV.1
NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF MEDICAL DEVICES
Dear Partners,
Attached is a revised document released by the European Commission that may help understanding some of the most important conséquences of Brexit if it happened that no agreement could be found between UK and EU.
The attached document is divided in two parts :
– Consequences for the (…) -
Implementation of Medical Devices EU-Regulation
12 September 2018, by Rene ClementMediMark Europe has made a selection of documents which may help you to understand and comply with the MDR (EU) 2017/745 which will apply from 26 May 2020. Some provisions of the MDR will come into force earlier (e.g.
regarding Notified Bodies and the Medical Device Coordination
Group). Some will apply later (e.g. regarding UDI labelling).
So, you will find below:
– A document which summarizes the necessary Technical Documentation for Compliance with the EU Medical Device Regulation (…) -
France Simplifies Regulations for Implantable and Class III Devices
12 June 2018, by Rene ClementDecision of the Council of State: The RCD decree concerning the need to send to ANSM, the French NCA, a summary of the characteristics for Class 2b implantable and 3 devices, has no legal basis and can only be canceled.
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Class 1 Reusable Surgical Instruments : Mandatory Conformity Assessment by a Notified Body
4 May 2018, by Rene ClementThe article 52 ( 7) of the new EU Medical Device Regulation 2017/745 requests the involvement of notified bodies for Class 1 Reusable Surgical Instruments.
The involvement of a NB was only mandatory under the current MD Directive 93/42/EEC for Class 1 sterile and Class 1 with a measuring function.
For Class 1 Reusable Surgical Instruments, the NB will deliver a CE Certificate for the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, (…) -
New adverse event terminology to be implemented in Europe starting from 2Q 2018
15 February 2018, by Rene ClementThe European Competent Authorities are keen to receive codified information on adverse events already ahead of the date of application of the upcoming IVD and MD Regulations. The adverse event codes developed by the International Medical Device Regulators Forum (IMDRF) are scheduled to be implemented in the European vigilance reporting starting from 2Q 2018 with one year transition time until their official enforcement.
Manufacturers are strongly advised to start mapping their internal (…)