Many times folks like you come to Document Center when they are unsure what standards are applicable for exporting their products overseas. And this is especially true during the certification process for exporting medical devices into the European market. Here at Document Center, we have a number of ways to help you out. And the easiest is to use our webpage of Harmonized Standards based on the European Directives (comparable to our federal regulations).
These lists are actually generated by the EU (European Union) itself, under what is called the “New Approach.” This is a way to achieve compliance to a directive by an EU member nation through the mechanism of standardization.
There are three main directives for the medical device industry. Luckily, for each of these directives there is a list of harmonized standards that meet the requirements of the legislative act. Here’s the information on the directive and a link to our page of harmonized standards for each:
- Directive 90/385/eec: Active Implantable Medical Devices
- Directive 93/42/eec: Medical Devices (MMD)
- Directive 98/79/ec: In Vitro Medical Devices
You’ll notice that the list specifies the documents only as EN (European Norm or European Standard) documents. However, when you click the link for each item, you see the record to purchase a BS EN document. The reason for this is that the EN documents are not released as stand-alone items, but always as republications as adopted by each European Union nation.
The BS EN copies are the official English Language editions for each EN document. However, any EN copy in English will be the same — only the national cover sheet administration information will change, depending on what country you purchase your copy from.
Something else to be aware of is the fact that when the EU adopts an international standard (like an ISO standard), it may include European administrative information about the source material. This is usually in the form of Annexes which cover how the adopted standard meets or fails to meet the requirements of the Directive it supports. For this reason, you may wish to purchase EN editions of International standards, even though the source International standard will not be modified by the adoption.
These lists do change periodically, so you may want to book-mark our pages and visit them every 3 to 6 months for a quick review…
Use Document Center’s website at www.document-center.com to find but and purchase the standards you need for regulatory compliance. Or you may prefer to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for additional information or to place your order. We are here to provide you with the standards support you need in order to manage your documentation requirements successfully.