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, advises on what needs to be fulfilled and how, and also provides support during execution. The goal is to realize regulatory compliance economically and to achieve product approval quickly.

CE Conformity and International Registration: Sound Advice and Support

Register and approve new medical devices. Or checking proven products and adapting them to changed regulatory requirements. The first step is always to check which requirements have to 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. What is the intended use? Which risk class is the product to be assigned to? With the EU MDR, there are changes in terms of classification. For example, new proofs may have to be provided for products that have already been launched. Which requirements apply?  

gempex offers consultancy and support in the selection and execution of the conformity assessment procedure according to EU MDR or international country-specific approval 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 documents are needed? What will be important? How is this to be documented? What can possibly be dispensed with?

The decisive factor is the product. The respective countries have different requirements: for Russian market access, for example, product tests must be carried out on site, while the US FDA requires a 510(k) application. It is important to show the respective authority that the specific product is safe. 

Here, it is important to efficiently have compliant, appropriate technical documentation available on-time for successful approval. 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 have to be systematically and actively collected, evaluated and reported. 

It is already important for approval to establish a stable process that contributes to improving the safety of the product, identifying risks and defining corrective measures. Requirements for this can be found in the EU MDR, ISO 13485:2016, the EU IVDR, as well as internationally, for example through US FDA Guidances or IMDRF Guidances.

For each product a Post Market Surveillance Plan has to be defined and implemented in the QMS. A safe action guideline that can be easily followed through. gempex supports the creation of a procedure instruction in which occasions, sources of information, responsibilities and actions are defined. And supports in setting up, documenting and safely applying the required processes.  

Here, in fact, all players in the supply chain, including distributors and importers, need to upgrade - as, for example, with the reporting obligations under the EU MDR. Details have been elaborated by gempex in a German language white paper for distributors and importers.  

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

The collection and evaluation of clinical data is not new. What is new is that the EU MDR, in particular, imposes dedicated requirements for clinical data over the entire product life cycle. 

A clinical evaluation is required, and it must also be submitted for 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 supports with the definition: are the available clinical data sufficient? What needs to be supplemented 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.

Meeting Increased Product Risk Management Requirements 

Requirements for risk management are defined in ISO 14971:2019. Results from post market surveillance and vigilance must find their way into the risk management file. Depending on the reported or documented event, a reassessment of the risk-benefit ratio may even be required.

And here, too, the requirements in some product classes have increased with the EU MDR. In addition, risk management is now mandatory for significantly more products.  

Does the risk management still correspond to the state of the art? What needs to be taken into account and how? What follow-up actions are required? gempex reviews the risk management file and helps to identify and eliminate deficits at an early stage. 

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

Approving the product internationally and placing it in the target market - an extensive project, a worthwhile venture! Canada, USA, Brazil, India, Saudi Arabia or Russia are considered attractive target markets for medical devices. 

Language and cultural peculiarities play an important role in international registration. Of course, country-specific regulations, prescribed procedures and documents as well. 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? What legalization is required? Is there an ideal approval prodedure for the product? Which documents are required? How are these to be processed and submitted? In which 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 safely through the project to successful international market access. On request, gempex also advises and supports on 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