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Changes to the Medical Devices legislation

As of May 26, 2021, the legislation for Medical Devices will change. We are following this change closely and this legislation may be very applicable to you. That is why I would like to ask your attention for the following!

There will be a new stricter standard for Medical Devices class 1. There will be a significant strengthening of the regulations to improve safety towards consumers and other users. The Medical Device guidelines are being replaced by a regulation. A regulation is more binding and has a stronger legal basis. Specifically: The MDD (Medical Device Directive 93/72 / EEC) goes to MDR (Medical Device Regulation EC 2017/745).

Before May 26 you can still bring a Medical Device class 1 product on the market according to the old guideline. Because the new regulation is strict and extensive, the costs are much lower if you go through this process now. With an MDD file you have an extra transition period before you actually have to create an MDR file. This transition period is 2 years. This gives you extra time to properly arrange the legislative change and, for example, to look for a Notified Body to register the product under the new MDR.

What is a medical device class 1 product?

A Medical Device class 1 product is a product intended for medical purposes with a low to moderate risk to the patient or user. Think of a skin cream for eczematic skin, or a nasal spray for short-term use. Often times these types of products resemble cosmetic formulations with a claim to improve a medical indication.

How do you register a Medical Device class 1 product?

A Medical Device Assessment for a class 1 product consists of a risk assessment and a clinical evaluation. In the risk assessment, a toxicological profile is drawn up for each ingredient in the product. The safety is calculated per ingredient for normal and excessive use. This determines whether the product is safe for use. The product as a whole is examined in the clinical evaluation. The beneficial effects and possible complications of the use of the product are evaluated on the basis of academic literature. This explicitly takes into account the pathological characteristics of the target group.

How can SkinConsult help?

A lot of technical documentation is required for the marketing of a medical device. One of the most important parts of this technical documentation is a clinical evaluation, in which the product is evaluated for safety. Because this part requires a specific piece of domain knowledge from both the medical side and the toxicological side, our customers are happy to outsource this clinical evaluation to us.

With our team of dermatologists and toxicologists, we can pool our expertise to provide the clinical evaluation of your products before the deadline of May 26. We work with dermatologists from the Dermatological Center Utrecht. This is a sister company of SkinConsult.

Do you have products at your company that fall within the scope of medical device? Please contact us via this link or call us on 003188-55546000


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