FAQ's about the Medical Devices Directive

When did the Medical Devices Directive become mandatory?

The MDD has been enforced since June 15, 1998.

What must a medical manufacturer do to comply with the Medical Devices Directive?

In order to meet the Directive, manufacturers must (1) determine the class of their product, (2) comply with the essential requirements, (3) implement the appropriate conformity assessment scheme, and (4) apply the CE Marking and issue a Declaration of Conformity.

Can we classify their products for them?

Yes, this is one of the many services that we provide. This can be done after the Initial Compliance Review visit. Following the visit, they will receive a Report of their Medical Compliance needs, including recommendations and a classification of their products.

Can our product fall under more than one classification, even though it is the same product?

Yes, if the product has more than one intended function. It is the intended purpose of the device and NOT the particular technical characteristics that determines the class of the product.

What happens if we come out with another product, do we have to start from the beginning?

The best thing to do is to advise the Notified Body of the new product or any new changes. (That is mandatory under the Medical Devices Directive.) However, it may be possible to simply adapt your existing quality system to include these new design changes and/or product additions. Testing on the product will most likely be necessary. Technology International can provide Design Review, providing a Report of necessary actions to take.

What is the difference between Annex V, Annex VI and Annex IV?

Annex V is the audit of the Production Process (equivalent to ISO 9002), while Annex VI is
the audit of the final inspection and test only (equivalent to ISO 9003). Annex IV (Product Verification) is when the Notified Body performs sample testing of the products. This may not, necessarily, mean that every product is tested. It may mean that a statistical sampling is performed.

If my company is already ISO 9000 certified or audited to the medical GMPs, can this help us meet the Medical Devices Directive?

Yes, that definitely helps. However, the Notified Body will be auditing your quality system
based on EN 46000. ISO 9000 or the medical GMPs are not sufficient by itself. EN 46000 is basically ISO 9000 (or EN 29000), plus specific medical requirements. Technology International can provide a Gap Analysis to determine where your quality holes are. In other words, what needs to be done to fill the gap between ISO 9000 and EN 46000.

How is the Medical Devices Directive different from other CE Marking Directives?

One of the main differences is that the Medical Devices Directive is more comprehensive than most directives. For example, unlike other directives such as the EMC Directive, the Medical Devices Directive ensures that the product performs properly and does what it is intended to do. The EMC Directive, on the other hand, only looks at Electromagnetic Interference; its not concerned with whether or not the product works. The Medical Devices Directive also includes EMC and Low Voltage requirements (If you comply with the MDD, you do not have to comply with other directives) and other labeling specifications.

What are some criteria used for classifying medical products?

Most medical products are either therapeutic or diagnostic. This criterion is helpful in determining the class of the product, mainly because it allows us to know the intended purpose of the product. Other things to consider are the following: how long the product is to be in contact with the patient (if the product is invasive, how long is it inside the patient?) and if the product is active electronic).