Hi! My name is Mercè Camps and I'm the director of GTF Pharma Consultancy.
GTF advise you about the legal terms to apply for your pharma product. We care about your business needs and help your product to accomplish the legislation.
We work for all publics:
“We are concerned about your technical needs, whether you are a small or a big company. If you need assessment in starting or improving your activities, feel free to contact us and we will find the solution that fits your specific needs”
Since 1991, Mercedes Camps Miró, founder, has managed Gabinete Técnico Farmacéutico (GTF), a Consulting Firm based in Barcelona, Spain, specialized in Regulatory Affairs and all other legal requirements from the Health Industry. GTF has a proven expertise at both the national and the international levels, in the business areas of Cosmetics, Medical Devices and Food Supplements.
GTF perform all necessary procedures to guarantee a full compliance with all current Health technical and legal regulations regarding products and facilities, so that time-to-market may be substantially reduced
GTF is a relevant member of Beauty Cluster Barcelona, Spanish Society of Cosmetic Chemists (SEQC) and the Health Self-Care Association (ANEFP). Mercè Camps, Director, is a Senior Pharmaceutical, member of the Royal Academy of Pharmacy, teacher at Barcelona´s University of Pharmacy and ex-member of the COFB (Barcelona Pharmacists Association).
We have a proven successful experience in solving sanitary issues. Our team of technicians will guide you to find the best solutions for your needs
CEO and Founder
Senior Technical Consultant
Senior Technical Consultant
Secretary of direction<br />
Single identification of the product: What will be possible with the new UDI system for Medical Devices?
In April 2013, the European Commission issued a recommendation concerning a common framework for a single identification system for medical devices in the EU. This was intended to lay the foundations for the EU's future identification and traceability infrastructure, in line with the latest developments worldwide.
Since then, the European Commission has promoted, through the publication of Article 26 of Regulation (EU) 2017/745 on Medical Devices, and Article 23 of Regulation (EU) 2017/746 on Medical Devices for In-Vitro Diagnostics, two essential initiatives aimed at providing coverage to the UDI system:
- The creation of the Medical Devices database Eudamed (whose name is an acronym for European Database on Medical Devices).
- The creation of the European Medical Device Nomenclature (EMDN) body, which provides support and facilitates the creation of the Eudamed database.
UDI: Identification that is primarily aimed at the safety of EU consumers
In short, the new Unique Device Identifier system – UDI will facilitate the traceability of medical devices. In parallel, post-market activities relating to product safety will also be stronger and will allow better monitoring by the competent authorities.
In addition, the European Commission, using EMDN, has created a FAQ document relating to the Unique Device Identifier – UDI. Read her now!
Unique Device Identifier (UDI) in Medical Devices
Click at the link to visit the European Commission’s Unique Device Identifier – UDI website, where you will find all the information about the European Medical Device Nomenclature (EMDN) initiative and Eudamed, the new European Medical Device'sDatabase.
This web portal, created by the European Commission, is a space that will allow you to know, at first hand, all the official information from the health authorities in the euro area and all the new developments in relation to the new Unique Device Identifier - UDI and its implementation process.