Last Revisions of the Forms: As you may know, EU NCAs make a strong distinction between forms dedicated to distributors/importators and those dedicated to end users.
It’s now formalized with the requested use of the templates you’ll find here attached.
When a Manufacturer decides to implement a voluntary recall, it is requested by some EU National Competent Authorities (NCAs) to review the user’s Field Safety Notice prior to launch the recall at the user’s level. We help the (…)
Most recent articles
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Recall (withdrawal) notification
4 September 2023 -
Some other services
3 September 2023, by Rene ClementFREE SALES CERTIFICATES
Free Sales Certificates (FSC) are often requested for registration of medical devices in Latin America countries, Asia and Middle East.
On request of a customer, MediMark Europe prepares the FSC and submits it to the Chamber of Commerce of Paris for signature. It takes about 4 weeks to received it back.
In case a legalization is necessary, MediMark Europe takes care of it through a third service company in France for legalization by the concerned Embassy in (…) -
Guidance documents for CE marking
3 September 2023, by Rene ClementIn order to save time for our customers, we have created series of Templates to help them to build their Technical Documentations.
We give them free of charge.
These main documents are: Checklist of the documents with shall be included in the full Technical Documentation Checklist of the documents that we need to keep in our European office for allowing us to present to Competent Authorities upon request General Safety and Performance REequirement list. The manufacturer (…) -
Incident reporting
22 August 2023, by Rene ClementIn case the Incident is reportable, we fill in, after agreement with the Manufacturer, an initial incident report according to the last MIR format and Annexes A-G.
We always request the final approval of the Manufacturer before sending the report. We follow up the actions of the Manufacturer such as historic lot analysis, incriminated product analysis, corrective action, etc... in order to write the final report. It is common that the concerned competent authority requests additional (…) -
Incident analysis and incident classification
22 August 2023, by Rene ClementWhen an incident or near incident is reported to us by the manufacturer, we conduct within 48 hours an analysis of the event versus the European Vigilance Guidelines to determine if it is reportable to the concerned Competent Authority. In any case, we fill in a formalized assessment form which may be audited by the Notified body at the manufacturer’s location.
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Keeping, maintaining and updating your technical files
22 August 2023, by Rene ClementFor answering to the requirements of the new MDR & IVDR Regulations (Article 11) regarding the availability of a permanent updated Technical Documentation at your EAR office, we offer you a private space on our internal fully securized Cloud for easy upload of all your documents.
These documents are treated with the highest confidentiality under our own certified quality system. This information is also important for helping us to better understand your company and products. We are (…) -
Operational assistance to labels
22 August 2023, by Rene ClementOur customers submit us their draft of labels. We check them and propose corrections, if any, for full compliance with the new Regulations and EN Standards.
We also provide guidance concerning the languages which should appear on the labels and Instructions for use. -
The new transitional deadlines for medical devices
1 August 2023, by Rene ClementREGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
New transitional deadlines for Medical Devices under the Medical Devices Regulation (MDR) :
– Higher risk class III and class IIb devices to 2027 instead of May 2024 at the latest.
– Class 1 devices (which need a NB certificate under MDR) (…) -
Key addresses for basic information
24 June 2023, by Rene ClementMediMark Europe has selected very helpful links for finding easily the updated official European regulatory documents and to feed some other regulatory needs.
-* MD & IVD Regulations : This site from the European Commission gives you the integral texts of the MD & IVD Regulations and much more. MEDDEV Guidelines for MDs & IVDs: : See GUIDANCE section. You will find the updated MEDDEV guidance and informative documents from the European Commission concerning the vigilance (…) -
Presentation of MEDIMARK® EUROPE
15 June 2023, by Rene ClementAuthorized Representative Responsibilities
Why MediMark Europe should be your choice?
Historic, references, key people
MediMark Quality Policy - Management Declaration