MEDICAL DEVICE REGULATION EUROPE

What is the difference between Regulation and Directive?

What permission is required to get your medical device to be sold in Europe?

 

There are quite differences between regulation and directive.

Firstly, a competent authority has 28 member states in the EU and each one of this member states have it’s own competent authority ,therefore, to publish and to direct are in their responsibility. The rules come from the European Commission as a pioneer. Notified body audit manufacturers to ensure compliance with European Union rules.

Secondly, there are 3 directives that are rule. The organizations need to follow this 3 directives in order to manufacture a medical device, to get permission and also to set up the medical device in Europe;

a) Active Implantable Medical Device Directive,

b) The Medical Device Directive,

c) The Directive of in Vitro Diagnostic Medical Devices.

Then, in medical devices, categorization is also so essential point because the categorization is related to the risk and patient. Thus, the higher the classification, the higher the risk means on the patient.

 

 

The EU MDR 2017/745 has 4 main categories for Medical Devices classification:

a)     Class I

b)     Class IIa

c)     Class IIb

d)     Class III

This goes from the products with low risk (Class I) to the products with high risk (Class III).

Besides, the EU Medical Device Regulation has established an identification (UDI) system that is similar to the United States Food and Drug Administration (FDA) system. If a manufacturer intends to provide or distribute medical devices into the EU marketplace, the labeling on those products should need to comply with this new UDI system. Compliance with the new MDR regulation is mandatory for medical device companies that intend to sell products in Europe. So, if the manufacturers want to sell their products in Europe, the manufacturers should have ISO 13485. In order to sell medical devices, notified body should visit and audit the manufacturers and to ensure their compliance with ISO 13485. When the medical device manufacturers have ISO 13485, it shows that the manufacturers follow ISO 13485 and related to the requirements so they are guaranteed to the competent authority in terms of following the medical device regulations within Europe.

However, the manufacturer may take the CE mark for medical devices. CE mark is a logo like a MDR certification that shows compliance with the medical devices directives. It shows that the device is suitable for the intended use and meets safety-related legislation and is also proof that it can sell the product in the European Union.

There is no doubt that the rules/regulations are law so the manufacturers need to follow these rules. Alternatively, if they do not follow these rules, they will not be allowed to sell their medical device in Europe.