Based on our many years of experience, we offer you a wide variety of services as a trustworthy partner. Always with the aim of providing our valued customers with the greatest possible flexibility. Our network of experts and consultants as well as our internal expertise will be happy to support you in a wide variety of subject areas.
If you also want to market your product internationally, you can concentrate fully on the development of your medical product, we take care of the approval.
In the first step, we plan the international approval for you and determine which classification your product falls under, whether clinical studies are necessary, establish contact with the foreign authorities, clarify the respective approval process for you and check which documents are required for approval .
After the formalities have been checked, we will accompany you in all preparations for approval by creating the country-specific technical documentation (STED) for you, checking existing STEDs and adding or improving them if necessary.
And we won’t leave you alone with the actual approval by the respective local authorities.
Regulatory Compliance Person Responsible (FERP / PRRC) Regulation (EU) 2017/745 requires in Article 15 (at least) one person who is responsible for compliance with the regulatory provisions. This person or persons are responsible for ensuring that
- the conformity of the products is appropriately checked in accordance with the quality management system under which the products are manufactured before a product is released,
- the technical documentation and the EU declaration of conformity are created and kept up to date,
- the post-market surveillance obligations under Article 10 (10) are met;
- the reporting obligations under Articles 87 to 91 are met,
- in the case of test products, the declaration in accordance with Annex XV, Chapter II, Section 4.1 is made.
For small and very small companies, however, there is the option of outsourcing this responsibility. This is where MEDAGENT comes in. – We would be happy to take over this service for you if required. Take advantage of our many years of professional experience in regulatory issues or quality management systems in connection with medical devices.
DATA PROTECTION OFFICER
The General Data Protection Regulation (GDPR) has been in force throughout the EU since May 25, 2018. In principle, whoever processes personal data of natural persons from the Union falls within the scope of the regulation.
Are your employees aware of the content of the GDPR and already comply with the General Data Protection Regulation? Have you already reported your data protection officer and created the list of processing activities?
No? – Then we are exactly the right contact for you. We help you to develop processes in your company that ensure the GDPR. With our support, we will enable you to ensure GDPR-compliant data protection management in the future.
Section 417 of the Food and Drug Modernization Act (FDAMA) of 1997 requires that any company involved in the manufacture, reprocessing, advertising, assembly, or processing of drugs and medical devices that wishes to import them into the United States must do one thing the FDA has to be registered and on the other hand has to show the cooperation with a United States agent.
With MEDAGENT Inc. we provide you with the U.S. Agents aside and thus cover the licensing requirements of the USA. Nothing stands in the way of your approval there!
UK Responsible Person
At the end of the 11-month transition phase, the United Kingdom separated from the EU on January 1, 2021 after years of arduous negotiations. In order to facilitate trade between the EU and the UK, the agreement contains some provisions for the medical technology industry.
Nonetheless, companies face new, additional hurdles as both parties are now viewed as separate areas of law and regulation. In our role as UK Responsible Person, we ensure for our customers, among other things, that their declaration of conformity and technical documentation are available and that the applicable UK MDR 2002 (amendment 2019) requirements have been implemented.
We will keep a copy of these documents and relevant certificates available and will forward them to the UK Medicines Regulatory and Regulatory Authority (MHRA) upon request. In addition, in consultation with the customer, we ensure the use of suitable conformity assessment procedures and generally work closely together as a link between the medical device manufacturer and the MHRA on various inquiries.
In order to facilitate our customers’ market access in Great Britain through the service of the UK Responsible Person and to meet the above requirements, MEDAGENT International UK Limited was recently founded.
As a result, MEDAGENT can now fully assume the role of UK Responsible Person. Contact us to find out more about MEDAGENT’s service and the UK medical device registration process.
Brazilian Registration Holder
Medical device manufacturers who want to market their products in Brazil must be registered with ANVISA. In addition, the manufacturer must name a contractual partner or license holder, the so-called Brazilian Registration Holder (BRH), as well as a Legal and Technical Responsible based in Brazil, who is named on the products as the manufacturer.
We have been with MEDAGENT do Brasil Ltda. act for you as a Brazilian Registration Holder and support you with the approval of your products on the Brazilian market.