Product Registrations
for Medical Devices and IVDs

EU medical device registration

For the approval of your medical devices the Medical Device Regulation MDR is decisive. It describes different conformity assessment procedures for medical devices.

• Conformity assessment on the basis of a quality management system and an evaluation of the technical documentation
• Conformity assessment on the basis of a type examination
• Conformity assessment based on product conformity testing

Technical documentation

The basis of an approval is the technical documentation (TD) according to Annex II and Annex III. It contains the evidence (physical or reference) of compliance with the requirements of the two Annexes and the general safety and performance requirements set out in Annex I. After successful completion of one of the various conformity assessment procedures, the medical device is approved. Only then may the CE mark be applied.

CE mark

By affixing the CE mark, the manufacturer indicates that the product complies with the applicable requirements laid down in EU harmonisation legislation concerning the affixing of the CE marking. In terms of MDR, this means that the manufacturer states that he complies with the requirements applicable to the medical device.

The symbol is shown in Annex V of the MDR. The deposited grid makes it clear which relative dimensions must be met.

US medical device registration

There are different things to consider for product approval in the US. The following topics provide a brief overview of topics that are relevant in this context.

Device listing and facility registration

In the US, a so-called "facility registration" and "device listing" must be carried out before products can be sold there. This is a formal step in which we can support you - so you do not lose valuable time on the way to US market access.

513(g)

The number 513(g) actually refers to a reference from the Federal Food, Drug, and Cosmetic Act - but it is used as an abbreviation in linguistic usage. In terms of content, it refers to a request for product classification from the FDA. This is a written application in which the FDA comments on whether, for example, a 510(k) is a possible approval method for the product.

Further information on this topic is provided in a comprehensive FDA guidance document, which you can download here.

You want to submit a 513(g) and need support? We offer you the right solution for this issue!

Premarket Notification 510(k)

As described in the previous paragraph, this is a reference to the FD&C Act. It describes the approval method of a "premarket notification". This is a very common procedure for approving products in the USA.

Although the creation of a 510(k) in the base is more or less identical for all products, it is quite specific due to many product-specific guidance documents and different 510(k) forms. The basis of a 510(k) is a so-called "predicate device" with which the own product is compared. Based on this comparison the "substantial equivalence" must be proven. Once this has been done, the product can be approved.

• How to find a predicate device?
• Which structure does a 510(k) need?
• Which proofs must be added?
• How is the substantial equivalence proven?

In these and many other questions on this topic we offer not only know-how but also active support in the preparation of your approval documents.

De Novo Program

Do you want to register a product in the USA but there is no Predicate Device? Do you think that the product should be classified in Class I or II? Then we will accompany you on the way to the FDA's De Novo Program for product approval

Premarket Approval

Your product is in Class III and requires premarket approval? Then the most complex FDA approval procedure lies ahead of you. We are your reliable partner for this demanding project!

Worldwide medical device registration

Medical devices must reach all patients in the world in order to provide their benefits. With our cooperation partners, we can support them even with the most demanding approvals, e.g. for the Chinese market.