Quality Assurance and Regulatory Compliance Framework

This page defines the regulatory positioning and compliance perimeter of THEDERMALFILLER S.R.L. within the legal framework of the European Union.

The content is strictly declarative and non-commercial. Its sole purpose is to describe the operational model, regulatory allocation of responsibilities, and compliance boundaries applicable to THEDERMALFILLER® under European Union and Romanian law.

THEDERMALFILLER® operates exclusively as an independent EU commercial intermediary coordinating sourcing, commercial structuring and transaction execution.

The company does not manufacture, import, repackage, relabel, store, distribute, or physically handle medical devices or medicinal products at any stage.

All references to products on this platform concern items supplied exclusively by authorised European Union manufacturers, marketing authorisation holders, or licensed pharmaceutical wholesalers operating under applicable EU legislation, including, where relevant:

– Regulation (EU) 2017/745 on medical devices (MDR);
– Directive 2001/83/EC and related pharmaceutical legislation;
– Good Distribution Practice (GDP) requirements;
– Applicable national transposition laws.

No statement published on this website shall be interpreted as a regulatory certification, product guarantee, conformity declaration, or assumption of regulatory responsibility by THEDERMALFILLER S.R.L.

Regulatory compliance, CE marking, batch traceability, storage conditions, transport compliance, and post-market obligations remain solely with the authorised economic operators placing the products on the EU market under their own licences and approvals.

THEDERMALFILLER® operates exclusively as an independent EU commercial intermediary coordinating sourcing, commercial structuring and transaction execution. Its function is strictly limited to coordinating structured B2B access, sourcing alignment, and commercial transaction execution between licensed healthcare professionals and authorised EU supply entities.

The platform does not qualify as, and shall not be construed as acting in the capacity of, a manufacturer, importer, distributor, wholesaler, retailer, marketing authorisation holder, authorised representative, or economic operator within the meaning of Regulation (EU) 2017/745, Regulation (EU) 2017/746, Directive 2001/83/EC, or any other applicable Union or national pharmaceutical or medical device legislation.

THEDERMALFILLER® does not manufacture, place on the market, import, store, stock, package, relabel, modify, reprocess, re-export, or physically handle medical devices or medicinal products at any stage of the supply chain.

All products referenced, quoted, or facilitated through THEDERMALFILLER® are supplied and delivered by authorised EU entities, with THEDERMALFILLER® coordinating sourcing, pricing alignment, and transaction execution within a compliant B2B structure.

Full and exclusive responsibility for regulatory conformity rests with the authorised supplying entity, including but not limited to:

– CE marking and conformity assessment procedures;
– technical documentation and regulatory files;
– batch release and quality control;
– pharmacovigilance and post-market surveillance obligations;
– storage conditions and cold-chain integrity;
– transport compliance and physical fulfilment;
– traceability, recall procedures, and regulatory reporting duties.

No statement on this platform shall be interpreted as a regulatory certification, endorsement, substitution, or assumption of obligations that EU law assigns to manufacturers, importers, distributors, authorised representatives, or marketing authorisation holders.

THEDERMALFILLER® neither substitutes nor replicates any regulated economic operator function under EU law. Its operational model is structured to ensure transparency, contractual clarity, and strict separation between commercial intermediation and regulated supply-chain responsibilities.

By engaging with THEDERMALFILLER®, users acknowledge and accept this clear allocation of roles and confirm their understanding that all regulatory obligations linked to product conformity and market placement remain exclusively with the authorised EU supplying entity.

All medical devices referenced, quoted, or facilitated in connection with THEDERMALFILLER® originate exclusively from authorised European Union supply chains operating under applicable Union and national regulatory frameworks.

Traceability, batch identification, Unique Device Identification (UDI) where applicable, CE conformity marking, technical documentation, declarations of conformity, instructions for use, safety information, post-market surveillance records, and all accompanying regulatory files are issued, maintained, updated, and retained solely by the authorised manufacturer, marketing authorisation holder, or licensed wholesaler legally responsible for placing the product on the Union market.

THEDERMALFILLER® does not create, modify, validate, certify, archive, or maintain regulatory or technical documentation relating to medical devices or medicinal products. The platform does not operate a quality management system within the meaning of Regulation (EU) 2017/745 or Regulation (EU) 2017/746 and does not hold independent technical files.

All documentary obligations under applicable EU law remain exclusively with the authorised economic operator legally designated for that role. This includes responsibility for:

– regulatory compliance documentation;
– conformity assessment procedures;
– maintenance of technical files;
– vigilance reporting and corrective actions;
– recall management and market surveillance cooperation;
– retention periods mandated by EU legislation.

Where regulatory documentation is lawfully requested by competent authorities or entitled professional entities, such documentation is provided directly by the authorised supplying entity in accordance with its statutory obligations and applicable legal procedures.

Information presented on this platform is strictly informational and declarative. It does not constitute regulatory documentation, certification, or legal substitution of the official documentation accompanying each product.

By engaging with THEDERMALFILLER®, users acknowledge and accept that full regulatory traceability exists at source level within the authorised EU supply chain and that all documentary and compliance responsibilities remain exclusively with the legally designated economic operator.

All content published on this platform is strictly informational, descriptive, and declarative in nature. It is intended solely to outline the operational and compliance perimeter within which THEDERMALFILLER® facilitates structured B2B access to authorised EU supply sources.

Nothing contained on this website constitutes:

– a public offer within the meaning of consumer or retail law;
– a medical claim, therapeutic claim, or clinical recommendation;
– a regulatory certification or conformity statement;
– a product guarantee beyond that provided by the authorised manufacturer;
– a substitute for official regulatory, technical, or product documentation.

This platform does not replace, replicate, or supersede:

– declarations of conformity;
– CE marking documentation;
– technical files maintained under Regulation (EU) 2017/745 or Regulation (EU) 2017/746;
– instructions for use (IFU);
– safety notices or vigilance communications;
– legally required disclosures issued by authorised manufacturers, marketing authorisation holders, or licensed wholesalers.

Access to or reliance upon information provided on this platform does not modify, reduce, or transfer any statutory responsibilities imposed by EU or national law upon manufacturers, importers, distributors, authorised representatives, wholesalers, or healthcare professionals.

Healthcare professionals remain solely responsible for:

– verifying product suitability for their intended clinical use;
– ensuring compliance with applicable national regulatory frameworks;
– observing professional standards of practice;
– complying with storage, handling, and documentation obligations under their own legal regime.

Use of this platform is strictly limited to licensed healthcare professionals and authorised commercial entities operating within the scope of regulated medical practice and applicable European Union legislation.

By accessing this website, users expressly acknowledge that the platform functions exclusively as a commercial intermediary interface and that all regulatory authority, product responsibility, and documentary validity remain exclusively with the legally designated economic operator under Union law.

In case of doubt regarding regulatory classification or economic operator status under EU law, the interpretation consistent with THEDERMALFILLER® acting as an independent commercial intermediary shall prevail.