Navigating the EU Medical Device Regulation | Event 1: For Companies New to Europe


You have two, FREE, virtual events to choose from focused on Navigating the EU MDR. 
This is Event 1 registration, specifically for new to the EU companies.
Event 2, on Thursday, October 5 is a detailed EU MDR presentation specifically for companies with knowledge of the EU, that registration is here.

Webinar Overview
·       What does EU MDR mean for your bottom line?
·       Learn how to navigate the EUMDR from:
Nina Brkuljan, Senior Commercial Specialist, U.S. Mission to the European Union, and
Maria Duguine, PhD Chemistry, Consultant, RQMIS (EU/UK/US regulatory consulting firm)
·       Understand the forces behind the regulation and the current implementation strategy.
·       Learn the certification process, time commitment and resources needed to be successful.

Who Should Attend?
·       Medical device producers including (stents, catheters)
·       Medication producers that use certain applicators
·       Certain cosmetics and food supplement producers
Gain knowledge about MDR, how it applies to your products, and more!

What is EU MDR?
The Medical Device Regulation (MDR) changed the European legal framework for medical devices and introduced new responsibilities for the European Medicines Agency (EMA) and for national authorities in the assessment of certain categories of products.

The MDR introduces new or revised responsibilities for EMA for:
·       Medicines with an integral device, such as pre-filled syringes and pens, and pre-filled inhalers;
·       Medical devices containing an ancillary medicinal substance to support the proper functioning of the device, for example drug-eluting stents, bone cement containing an antibiotic, catheters coated with an antibiotic agent and condoms coated with spermicides;
·      Medical devices made from substances that are absorbed by the human body to achieve their intended purpose; and
·      Borderline products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements (European Medicines Agency, 2022)

Selling or planning to sell to the EU - you won’t want to miss this!

We invite you to explore the wide variety of events that we offer to help U.S. companies expand their global sales.

Event 1: Navigating the EU Medical Device Regulation
Event 1: Navigating the EU Medical Device Regulation
11:00 - Welcome by Jacqueline Torcellini, U.S. Commercial Service (Domestic Team)
11:05 - Introduction by Lourdes Castellanos, U.S. Commecial Service (Düsseldorf)
11:10 - Speaker Introductions  by Jacqueline Torcellini, U.S. Commercial Service (Domestic Team)
11:15 - TBD by Maria Duguine, PhD.,Regulatory/Quality Consultant, RQMIS
11:30 - TBD by Nina Brkuljan, Senior Commercial Specialist, U.S. Commecial Service (Brussels)
11:45 - Q&A
11:00 AM
12:15 PM

Jacqueline Torcellini

Jacqueline Torcellini is a Senior International Trade Specialist with the U.S. Commercial Service, Middletown, Connecticut Office, a division of the U.S. Department of Commerce International Trade Administration. She has been providing international business support for over a decade and has assisted scores of businesses to either start exporting or expand their existing international business.

holds a Master’s Degree in Political Science, International Relations from Southern Connecticut State University. Her years of experience in business development, financial management, operations, training, and communications, turned out to be a great foundation from which to expand to the intricacies of conducting international business.
Jacqueline believes U.S. companies can strengthen their business by diversifying their client portfolio through expansion to appropriate international markets. She is excited to be able to support U.S. companies, by helping them identify top markets for their products, determine the best market entry strategy and how to harness the resources available to them on the federal and state level, so they can make exporting a part of their business growth strategy.

Lourdes Castellanos

Lourdes Castellanos, Commercial Specialist
U.S. Commercial Service - Dusseldorf

Lourdes Castellanos joined the CS Dusseldorf Team in October 2022. Prior to working for the Commercial Service, Lourdes worked for the U.S. Department of State at the General Consulate in Frankfurt. From  2014 - 2019, she supported the U.S. Embassy in Mexico City as the Senior Marketing Specialist for the Foreign Agricultural Service. 

Lourdes holds a B.A. in Communications and Journalism as well as an M.A. in Corporate Communications and Crisis Management, she speaks English, Spanish and German.

Maria Duguine, PhD Chemistry

Consultant, RQMIS

Dr. Maria Agustina Duguine is a European and South American specialist based in Barcelona, Spain office of Regulatory/Quality Management Information Source (RQMIS).  Since 1996, RQMIS has been providing companies with strategic guidance on how to effectively navigate the medical device, pharma, nutraceutical, and cosmetics regulations all around the globe. Maria has over eight years of experience working in the areas of regulatory and quality management. She served as the manager of regulatory affairs and quality assurance within various companies where she managed, maintained, and prepared registrations and notifications to ensure product compliance in therapeutic areas such as dietary supplements, pharmaceuticals (OTC and homeopathic), biopharmaceuticals, medical devices, cannabis therapy and cosmetics. She has wide experience into EU MDR 2017/745, IVDR 2017/746, biopharmaceutical development, and product registrations in the United States, Brazil, and the EU. She worked on the regulatory strategy documents for both medical device and invitro diagnostics, generating them and creating the corresponding regulatory documents submitting to different health authorities like FDA and EU Notified Bodies. This has been a key for assisting companies in the transition from the Europeans Directives to Regulations, also integrating FDA compliance.  Maria was involved in several in vitro diagnostic devices for woman health devices for allowing early detection of diseases to substantially improve therapy success, based on epigenetic biomarkers which allow early and reliable cancer diagnostics. 


Maria has experience in technology transference, submissions, life cycle, labeling and marketing strategies for United States, EU and Latin America (mainly ANVISA, COFEPRIS, ANMAT, INVIMA) for dietary supplements and medicines. She was involved in product placement for one of the largest pharma and dietary companies in the United States. and has an expert understanding of the regulations and directives for different countries around the world.


Dr. Duguine holds a PhD in Chemistry and Pharmacy and is an active member of the Argentine Association of Cosmetic Chemists. In addition to her work as a consultant she is also an adjunct Professor of Chemistry at the UB University in Argentina.  She is fluent in Spanish, English and Italian with intermediate skills in French and Portuguese.


Nina Brkuljan

Senior Commercial Specialist, U.S. Mission to the European Union

Nina Brkuljan

Senior Commercial Specialist, Artificial Intelligence, Competition Policy and Healthcare

U. S. Department of Commerce | U.S. Mission to the European Union

Nina Brkuljan is a Senior Commercial Specialist for the U. S. Department of Commerce, International Trade Administration based in Brussels, Belgium. Ms. Brkuljan provides insights to U.S. exporters on Artificial Intelligence, Competition Policy and Healthcare, specifically on compliance with the MDR/IVDR. She also participates in the U.S. – EU dialoge on eHealth and European Health Data space.  Prior to her work at the U.S. Mission, she was the EU Affairs Association for Boehringer Ingelheim and a Committee Member of the European Health Parliament.  She has also worked for Novartis in the EU Government Affairs position and the European Commission, Responsible for monitoring of EU-U.S. cooperation on eHealth.