We’re well aware that the title of our first blog entry is, well… a little intense, to say the least. But that’s because the Life Sciences is an intense business. Localizing the Life Sciences, in turn, adds its own fair share of exclamation points to the pandemonium. What with all the directives, the PCA risks, RoHS compliance, fretting over levied fines, and disparate regulatory authorities between every country, you’ve got enough on your plate already without having to digest the lot of it into a mass of worldwide languages.

In line with the air of intensity, we’ll keep this introduction short and sweet.

Our company is MedL10N, the only Asia-based language service provider with an undivided focus on delivering translation and localization services to the Life Sciences industry. You can find out more information on our website, http://www.medl10n.com/.

The point of this blog is to help you stay informed. (And occasionally entertain you with our uproarious wit. A-hem.) The information we post won’t always be 100% related to localization specifically, but it will be directly related to the success of your medical products in the global market.

So without further ado, let’s get to work. Here’s the first of our time-sensitive topics du jour:

THE DREADED DIRECTIVE 2007/47/EC

So how’s your organization faring with the new directive? Although it’s already been transposed into law as of mid-March, we think it’s important to really familiarize yourself with its contents so that you can ensure the compliance of your medical products.

For those who aren’t familiar with Directive 2007/47/EC, or for those who want to brush up (it never hurts to double-check!), here is a little information about the Directive and how it applies to you.

What it is:

Directive 2007/47/EC is a new European Commission directive that modifies two existing directives:

1. Directive 90/385/EEC on active implantable medical devices, and
2. Directive 93/42/EEC on medical devices.

Originally published on 21 September 2007, Directive 2007/47/EC required transposition by Member States of the EU by 21 December 2008. The Directive was transposed into law as of 21 March 2010. It is important to note that the Directive does not provide for a period of transition. This means that any medical device that is placed on the market or put into service after 21 March 2010 must conform with the new requirements of the revised directives.

If you like, you can pick through Directive 2007/47/EC on EUR-Lex.

Why Medical Device Manufacturers Should Care

Selling products in the EU requires a CE mark. Obtaining the coveted CE mark can be quite challenging and requires manufacturers to declare their conformity, which must be assessed by a Notified Body. Conformity requires adherence to the published directives.

Manufacturers/distributors are not required to comply with the new requirements introduced by Directive 2007/47/EC before 21 March 2010. Since there is no provision for products already on the market, any medical device legally placed on the market or put into service PRIOR to 21 March 2010 can continue to be marketed and used after 21 March 2010.

Highlights of What the Directive Instructs

1. Software is defined as an active medical device. Article 1 of the Directive defines medical devices as “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its Manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings ….”

   Annex IX, Classification Criteria, Software added “Stand alone software is considered to be an active medical device.”

2. Software validation is defined as an “essential requirement” in Annex I, 12.1a. Specifically, it states: “For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development, lifecycle, risk management, validation and verification.”
3. A single-use medical device is defined as a “device intended to be used once only for a single patient.”
4. The Principal Mode of Action, not the Intended Use, will determine whether a product is classified as a medicinal product or device and, thus, which Directive that device falls under. For details, see Article 1, paragraph 5c.
5. Any issue regarding the delay in decision for reprocessing medical devices must be reported to the Parliament before 5 September 2010, according to Article 12 of the Directive.
6. A manufacturer can appoint a single European Authorized Representative (AR) to act and be contacted in lieu of the manufacturer in terms of meeting the obligations by the Directives for all classes of devices.
7. According to Article 14, Member States may now require information on Class IIa, IIb, and III devices when such devices are put into service within their territory.
8. Notified Bodies are required to conduct inspections of design documentation for a representative sample of devices using industry standard statistical techniques commensurate with the risk of the device.
9. The European Databank will be operational according to Article 14a of the Directive.  This allows registration of the Authorized Representative and data on clinical investigation added.  This Databank will be implemented by 5 September 2012 and operational functioning will be evaluated on 11 October 2012.
10. Outsourced (OEM’d) design and manufacturing must be monitored more closely.  If a third party is designing or manufacturing a medical device on your behalf, you must prove that you have adequate controls in place to ensure the continued efficient operation of the quality system.
11. Records must be retained for at least 5 years for inspection by the Competent Authorities for the useful life of the product or 5 years from the date of manufacture, whichever is greater. For implantable devices, records must be kept for 15 years from the time the last product was manufactured.
12. The definition of the central circulatory system has been expanded to include the vessels aortic arch (arcus aortae) and descending aorta (aorta descendens) to the aortic bifurcation (bifuractio aortae).  Any device that comes in contact with these vessels will now be considered Class III.
13. Additional requirements have been added to the Essential Requirements, Annex I for Ergonomic design (ER 1), Level of training and knowledge of the user (ER 1), Clinical Evaluation (ER 6a), and Biophysical modeling (ER 7.1).
14. Per Essential Requirement, 12.6(q), the “date of issue or the latest revision” of the Instructions for Use (IFUs) must now be revision controlled.
15. Devices with phthalates must be labeling accordingly according to Annex 1, 7.5.
16. According to Article 1(k), clinical data is now required for all devices, including Class I.  Clinical data is defined as “safety and/or performance information that is generated from the use of a device”.
17. Annex I, Essential Requirements, Section 6a indicates that “demonstration of conformity with the essential requirements must include clinical evaluation in accordance with Annex X, Clinical Evaluation.”

And that’s it for the new Directive 2007/47/EC.

To lighten things up a bit, we would like to close with a joke.

Why do nurses carry red pens?

…

To draw blood.

Badoom-ching!

That concludes our first entry. Thanks for reading, folks.

.

.

---