Medical product certification - process and obstacles

Medical devices that are manufactured, purchased and utilized in Germany or the EU generally enjoy a high level of trust. Because if you know the German bureaucracy, medical products in particular would have to have gone through lengthy testing and approval procedures before they are offered on the market. Right?

In this article we will clarify which requirements and conditions medical products really have to meet according to the Federal Institute for Drugs and Medical Devices (BfArM) and which steps they have to go through in order to finally be allowed for sale. Find out what hurdles and challenges manufacturers and sellers in medical technology design could face.

The "approval" process - path to the CE mark

Medical devices are understood to mean all products that are developed for medical use in humans apart from pharmaceuticals. All these examination and diagnostic devices, instruments, healing materials, bandages and much more must be marked with the CE certification in the EU. This "Conformité Européenne" indicates whether medical devices are "compliant" with the general safety and performance requirements. But what does that mean and how is this conformity confirmed?

In contrast to the USA and other countries, European manufacturers confirm the conformity of their medical devices themselves under certain circumstances and thus confirm that they comply with the relevant guidelines of the MDR approval (Medical Device Regulation). This type of approval or declaration of conformity was introduced in 1995 to propel the free market economy in Europe.

Of course, this completely autonomous procedure is not possible with all medical devices; if the safety and performance requirements are very high, the MDR approval is carried out by "designated bodies" depending on the potential risk factors of the medical devices. These are official institutions that have specialized in testing certain product categories in risk classes IIa, IIb and III - only manufacturers who offer products in risk class I can certify themselves. If you want to bring a medical device onto the market or revise an existing one, we can actively support you with our expertise in the field of formative evaluation.

held+team | Medical product certification - process and obstacles

Possible obstacles with approving medical products

In addition to the examination by the designated bodies, the approval of medical devices can also be made more difficult and less independent than previously assumed by other factors. 3 explicit cases are mentioned here by the BfArM; the special regulations for certain types of products, the special approvals for new types of medical devices whose testing is urgent for various reasons, and the testing and approval of medical devices with medicinal components.

Special regulations: Clinical BfArM approval of medicinal products

In addition to the 4 risk classes of medical devices, a distinction is also made between products that have to be subjected to clinical testing or are used for performance evaluation purposes (in-vitro diagnostics); The latter are diagnostic instruments that determine diseases and body values ​​using biological samples - for example blood glucose meters, pregnancy and Covid tests.

Since the medical devices for in-vitro diagnostics go through more extensive conformity assessment procedures, these are not written down in the MDR but in the MPV (Medical Product Regulation). The clinical evaluation in turn describes an approval by the BfArM, which requires subjecting safety and performance aspects to a practical test; for example because the current study situation for the approval of the respective medical devices is not sufficient.

Special regulations: When it needs to go quickly

Again and again it happens that medical products have to be manufactured or brought onto the market particularly urgently. Under certain circumstances, which are determined by the BfArM, a special approval can be applied for to receive the approval for a medical device; this is the case when a regular conformity assessment cannot be waited for due to acute urgency and there are no alternatives to the respective product.

Consultation procedure: Medical devices with a medicinal component

There is a middle ground between purely physical medical products and pharmaceuticals; Medical products whose medicinal components contribute to the actual purpose - for example nebulizers or patches with certain active ingredients. The approval of these medical devices is regulated by the so-called consultation procedure. The European Medicines Agency (EMEA) or another drug approval authority checks the medical device depending on the prominence, quality, usefulness and safety of the drug.

If you have any further questions about medical devices and their approval, you are welcome to contact us at any time. We look forward to your inquiry.

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