Regulatory Affairs - Safe Worldwide Product Approval of Medical Devices

A wide variety of requirements exist worldwide for the registration and approval of medical devices, combination products and in vitro diagnostics (IVD). Standards, regulations and norms are continuously updated, requirements are increased or newly defined. The medical technology industry must keep pace with these requirements in order to ensure the sustainability of its business activities. The smooth handling of approval processes plays a decisive role in this.

gempex offers safe navigation through the world of regulations, advices on what needs to be fulfilled and how, and also provides support during execution. The goal is to realize regulatory compliance efficiently and to achieve product approval quickly. In other words, to bring the medical device into circulation and make it available in compliance with regulatory requirements. 

CE Conformity and International Registration: Sound Advice and Support

Registering and licensing new medical devices or adapting established products to changed regulatory requirements. The first step is always to determine which regulatory requirements must be met. Here, a targeted approach based on reliable knowledge of the regulations is essential! 

The requirements of the respective country that is aimed as the target market must be met. Based on the intended use, medical devices are assigned to different risk classes. With the implementation of the EU MDR, for example, there are changes in terms of classification. What additional requirements and further proofs must now be fulfilled or provided for products already launched on the market?  

gempex offers consultancy and support in the selection and execution of the conformity assessment procedure according to EU MDR as well as in the implementation of country-specific licensing and registration procedures. This succeeds due to the well-founded experience from a multitude of nationally and internationally realized projects. Achieve conformity safely and maintain it sustainably.

Technical Documentation for Successful Approval: On-time, Compliant, Customized 

Technical documentation accompanies the entire product development process.  It must be complete and meet the requirements. Which questions about the product does the technical documentation answer? The general answer: All of them! But which documents are needed for specific licensing and registration procedures? What will be important and how is this to be documented according to requirements? Also: What can and should even be dispensed with?

The product and the respective country-specific procedure are crucial. For example, for Russian market access, product tests must be carried out on site, while the US FDA requires a 510(k) application. 

Here, it is important to efficiently have compliant, appropriate technical documentation available on-time for successful licensing. No more, but also no less. Tailor-made.

gempex checks whether a technical documentation is complete, identifies the need for adaptation to new or country-specific regulations and, if desired, also provides support during implementation: compiling, preparing, creating or updating documents. This is the core competence in the area of Regulatory Affairs Medical Devices. 

Post Market Surveillance and Vigilance - Anchoring Efficient Processes Securely in the QMS 

Active market surveillance after the medical device has been placed on the market and responding to incidents. Companies in the medical technology industry are obliged to do this. Information from the market must be systematically and actively collected, evaluated and, if necessary, reported. Unacceptable risks must be identified and corrective measures taken. 

Also here, country-specific details must be taken into account and the processes of the quality management system must be adapted accordingly. Requirements in this regard can be found in the EU MDR, ISO 13485, the EU IVDR, the national MPDG, as well as internationally in US FDA or IMDRF Guidances, for example. A post-market surveillance plan must be defined for each product and implemented in the QMS. A safe action guideline that can be easily followed through. 

For a long time now, other economic operators have also been explicitly involved in the medical device life cycle. gempex has elaborated details in a German language white paper for distributors and importers.  

gempex supports the preparation of process instructions and PMS plans, in which occasions, sources of information, responsibilities and duties to act are defined, as well as the implementation in the company. And supports in setting up, documenting and safely applying the required processes.  

Clinical Data, Clinical Trials, Clinical Evaluation: Creation and Updating

The need to collect and evaluate clinical data is not new. What is new, however, is that the EU MDR, in particular, imposes dedicated requirements on clinical data and their collection over the entire product life cycle. 

A clinical evaluation is required. It must also be submitted as part of the conformity assessment and product approval. In which rhythm and on the basis of which sources are clinical data to be updated? When is a PMCF study required?  Which clinical data are relevant? How has the clinical evaluation to be structured? 

Here gempex provides support, for example, in deciding what needs to be added in individual cases in order to comply with the regulations. The range of services includes the development of a clinical evaluation plan as well as support in the preparation of the clinical evaluation report and the PMCF study, if required.

International Registration and Product Import - Local Representation, Document Management, Customs

Language and cultural peculiarities play an important role in international licensing. As do country-specific regulations, prescribed procedures and documents. Health Canada, ANVISA (Brazil), US FDA, S-FDA (Saudi Arabia), CDSCO (India) - each authority has its own requirements. Here, know-how from numerous internationally accompanied market accesses ensures project success. Possibly advantages of the MDSAP can be used.

Who is available as a potential registration partner? Is there an ideal approval procedure for the product? Which documents are required? How are these to be processed and submitted? At what cycle is the registration to be renewed? How do the products pass through customs smoothly?

gempex offers efficient management of the approval process, knows about numerous pitfalls in international product launches and accompanies customers reliably through the project to successful international market access. On request, gempex also advises and supports individual aspects. Efficient, fast, targeted.


  • Customized technical documentation according to EU MDR or international country-specific requirements
  • Secure knowledge of international regulations and procedures
  • Overall project management for international approvals 
  • Taking over the contact with Notified Bodies or Authorities/Dealers/Consultants in the international area
  • Reliability in realizing an efficient, compliant and speedy solution