Medical Devices Vigilance regulations in Switzerland

Swissmedic is the central Swiss supervisory authority for therapeutic products. It is a public service organization of the federal government with headquarters in Bern.

Its core competence includes

• licensing medicines
• granting authorizations to manufacture and distribute wholesale, and inspecting facilities
• monitoring medicines and medical devices already on the market
• controlling the traffic of narcotics
• laboratory testing of medicine quality
• drafting laws and standards

Medical devices Vigilance:

In order to monitor medical devices already on the market, manufacturers and distributors placing medical devices on the Swiss market are required to report all serious incidents and recalls that are carried out for safety reasons.

• The European guidelines on vigilance to report procedure applies also in Switzerland. MEDDEV 2.12/1.
• Incidents: people responsible for the product on the market, should report incidences to Swissmed. An information sheet from Swissmedic describes the legal obligations and the reporting procedure for serious incidents.
• Recalls: In case of recall of a product from market, Swissmedic should be informed.

To get more information about Vigilance procedure in Switzerland, take a look at the following link:

Vigilance: reporting serious incidents with medical devices

Medecins & medical devices Regulations in UK

Here, you can find a quite useful article in pdf format from the MHRA website about :

What is the MHRA?
How does licensing and authorisation work?
How does the MHRA monitor the safety and quality standards?
Influencing policy

Complex Biomedical devices 2

As sue has mentioned in the comments of the previous post, at the first glance, cool.click™may seem a combination product, however it has to be categorized in one group to get through the legislations.

Normally, a device that is just used to DELIVER a drug ( as a syringe) is considered as a pharmaceutical product and should get through pharmaceutical legislations. However, sometimes this is the company who decides what is a main function of the product and how it wants to introduce its product and then gets through negotiations with legislative organisations to reach to an agreement about the nature of the product.

Does the device do something more than the drug delivery? Do mechanical parts or electronical parts have physical roles in the treatment,etc? These questions arise while deciding the category of the product. an example may be a coated stent.

In conclusion , It should be considered that the answer to these questions are not always very clear. Sometimes a product may be accepted as a medical device in Europe while as a pharmaceutical product in US and vice versa. The descision is made after discussions between companies and EMEA in Europe or FDA in the US.

Complex biomedical devices

cool.click
cool.click™ is a needle-free device that delivers Saizen® through the skin The drug is delivered subcutaneously and provides the equivalent biological dose of Saizen® as do needle injections. Because it is needle-free, cool.click™ reduces pain and anxiety for patients that are undergoing daily treatment for Growth Hormone Deficiency. Looking at this product, in which group would you place it: is it a medical device or pharmaceutical product?

Complex biomedical devices; combining Pharma & medical technology

In the past, there used to be a quite distinct cut between medical devices and pharmaceutical products and intersection of devices and drugs occurred only at use. Examples of these kinds of medical devices are PCA pumps and imaging agents.

However, nowadays Drugs are added to devices to add value to medical devices and improve their function and efficiency. Moreover, sophisticated drug delivery systems integrate drugs and devices. We can mention transformal patches, coated catheters and drug eluting stents as some examples.

It is not really clearer if a combination of device-drug should be classified as a medical device or a pharmaceutical product. This becomes extremely important when it comes to regulatory affaires. Currently regulatory systems for pharmaceutical products and biomedical devices are totally different and not always really easy to handle for companies. Mostly this classification is claimed by the company and challenged by authorities. However, that may not end to a same classification in all the regions of the world. These kinds of Complex devices may be accepted in one region as a pharmaceutical product and in the other one as a biomedical device requiring two completely different procedure in the view of clinical trial and regulatory procedures. The problem may be much more important when it comes to devices combined with stem cells, tissue engineered materials and so on.