A Technical File is proof that a medical device complies with the essential safety and health requirements set down by the relevant Directive(s). Technical Files are required for all classes of medical devices – Class I, Is, Im, IIa, IIb, III – and they must hold essential information about the medical device, including photographs and diagrams. A Technical File can be compiled in any of the official languages of the EU. However, English is the most commonly used. An up to date electronic or hard copy of the file needs to be kept available in Europe allowing it to be presented to any EU Competent Authorities upon request. Manufacturers based outside the EEA are to make it available at the address of their European Authorized Representative. As part of the CE Marking process, it is also advised that an external expert reviews the Technical File.
Views: 2364 Obelis Group
"When a cosmetic product is placed on the market, the responsible person shall keep a product information file (PIF) available for it" - Cosmetic Regulation EC 1223/2009, Article 11.1 Learn about the basics of the "EU Dossier", technical file or more appropriately under the Cosmetic Regulation EC 1223/2009 - Product Information File as well as the importance of the EU Responsible Person in compiling, keeping and updating this crucial piece of your product compliance and the timeline to doing so. Article 11 - PIF Contents 1. Product Description & intent of use 2. Cosmetic Product Safety Report (CPSR) - Safety Information (Part A), Safety Assessment (Part B) 3. Method of Manufacture & GMP (ISO 22716) 4. Proof of effect claimed 5. Data on Animal Testing 6. Labeling You will get an in-depth view of each of the above elements along with the expected timeline to gaining compliance, in turn, allowing you to be that much closer to achieving EU Compliance and success in the EU Market!
Views: 3232 Obelis Group
www.obelis.net Learn about the importance of the CE Marking particularly concerning European compliance and what is required in order to affix the CE Marking to your products. Topics covers: -Complexity of the CE Marking -Steps to obtain the CE Marking -Classification in accordance with the applicable EU Legislation(s) -Identification of the Essential Safety & Health Requirements and proper Conformity Assessment procedures -Building evidence of compliance within Technical Documents (aka EU Dossier) -Certification Procedures -Pre-Market Notification to the Competent Authorities -Affixing the CE Mark -EU Market entry! Please feel free to contact us with any questions! www.ObelisMedical.net/contacts
Views: 3761 Obelis Group
www.obeliscosmetics.net - EU Cosmetics Notification explained Topics to be covered: What is a notification process? What is CPNP portal? Which information has to be provided in CPNP? Who has access to CPNP? What is the role of the Responsible Person (RP) in the notification process? What are the risks related to notification process?
Views: 467 Obelis Group
www.obeliscosmetics.net EU Cosmetics Regulation EC 1223/2009 Article 4.1- EU Responsible Person Requirement Topics to be covered: How do you designate an EU Responsible person? How should the manufacturer choose who is to serve as their EU Responsible Person? Who needs an EU Responsible Person? What happens when the EU distributor makes changes to the product? What are the risks of electing a distributor? What is the procedure to replace your current EU RP?
Views: 1188 Obelis Group
www.obelis.net Learn about Free Sales Certificates (FSC), the importance of the issuing (reference) country and how to use them to achieve greater international distribution and success! Obelis is a professional European Authorized Representative (EC REP) & Responsible Person (EU RP) based in Brussels, Belgium. We are specialized in serving as EU vigilance contact point and supporting Regulatory compliance across all 32 EEA countries.
Views: 1438 Obelis Group
The final artwork of a cosmetic product labelling, must follow certain rules - find out how you can achieve your product's compliance with the regulations of the EU market!
Views: 305 Obelis Group
www.obelis.net Check out this video for a nice introduction to the many important factors to consider in selecting who shall serve as European 'Authorized Representative' (EC REP) and the invaluable legal & regulatory role they play in successfully exporting your medical devices or other products to Europe. Topics covered: -Defining European Authorized Representative (EC REP) -Medical Device Directive (MDD) 93/42/EEC reference to EC REP -How to designate an E.A.R. -Factors to consider in choosing the right E.A.R. -Who can serve as European Authorized Representative -What should the EAR do for legal manufacturer (brand owner)? -What are the risks to consider in choosing an EAR? -What are the risks in designating a distributor as EC REP? -What is the procedure to change EAR? Enjoy and leave us a note in the comments! Www.Obelismedical.net/contacts
Views: 1100 Obelis Group
Created with Movavi Video Editor Business https://www.movavi.com/videoeditorbizmac/?c=vembiz5
Views: 223 Obelis Group
Obelis exhibited at Cosmoprof North America for the 6th year straight, showcasing our European Responsible Person services. Obelis provides compliance consultancy, Registration, labeling/language support, Safety Testing & Assessment guidance and much more towards cosmetic and personal care manufacturers exporting to any and all of the 32 EEA countries.
Views: 313 Obelis Group