Recent Changes to the MDD

Recent Changes to the MDD

New Approach EU Directive 2007/47/EC on Medical Devices is the first significant update to the outgoing Medical Devices Directive 93/42/EEC and will impact all manufacturers that sell, or plan to sell, medical devices in Europe and potentially other countries of the world that currently recognize and accept CE marking as a means of market entry into their own territory.

14 Major Changes to the Revised MDD

1.	Clinical data is now expected for every device, which includes class I

	A fresh definition of "clinical evidence" is now in place and more emphasis is being placed on the regulatory authorities in terms of ensuring compliance. Indeed the UK Competent Authority has already run a significant workshop for Notified Bodies in this area to reinforce the importance of this issue. "Clinical data" is defined in the relevant modified ERs and this data requires clinical evaluation according to a much-modified Annex X.

2.	Single use devices

	Definition of SUDs is clarified to state that such devices are used once only and on a single patient. Manufacturers are required to indicate the risks if such devices are re-used and this must be included in the instructions for use (IFU).

3.	Records retention periods

	The requirement for retaining records is now 5 years from date of manufacture of the device or over the useful lifetime of the device whichever is greater. Implantable device records must be kept for 15 years after the last device is manufactured.

4.	Choice of conformity assessment routes

	Manufacturers of Class I sterile and Class I measuring devices are permitted to follow the Annex II (full quality assurance) route to compliance, representing a more flexible approach to CE marking for manufacturers of these devices.

5.	Assessment of key subcontracted activities e.g. design and manufacturing

	The new requirement places more emphasis than before on ensuring adequate control by the manufacturer over its key subcontractors — UL has always operated a robust assessment of its clients to ensure these levels of control are in place in line with these new requirements.

6.	Assessment of technical files

	Notified bodies are now expected to sample these documents in line with a more statistical sampling approach, taking into account similarities and differences between devices within generic device groups (Class IIb) or device subcategories (Class IIa) and overall risk. UL has always operated a well-defined risk based sampling plan for assessment of such documents which we believe is in line with these new requirements.

7.	Authorized Representative (AR)

	The AR is expected to be the primary contact and primary active party in resolving device issues (all device classes) and will be contacted directly by the authorities.

8.	Software classification

	Software used for diagnostic and therapeutic purposes is now classified as an active medical device whether stand-alone or combined with the device and will be required to comply with the relevant ER(s).

9.	Relationship with Machinery Directive (2006/42/EC)

	If a medical device, taking into account intended purpose, also meets the definition of a product under the Machinery Directive the manufacturer must demonstrate that the relevant ERs of that directive are also met. For products requiring notified body intervention under the MDD, the notified body will need to be satisfied that the relevant provisions of the Machinery Directive are met.

10.	Personal Protective Equipment Directive (89/686/EEC) (PPE)

	If a device classified as a medical device also falls under the PPE Directive based on intended purpose then the manufacturer must fulfill the basic health and safety requirements of the PPE directive. For products requiring notified body intervention under the MDD, the notified body will need to be satisfied that the relevant provisions of the PPE directive are met.

11.	Control of IFU (Instructions For Use)

	It is a new requirement that IFUs are revision-controlled by an appropriate mechanism. Such as date or revision number or by some other appropriate means.

12.	Central Circulatory System

	The new definition now includes the aortic arch (arcus aortae) and the descending aorta (aorta descendens) and the aortic bifurcation (bifurcatio aortae). All devices coming into contact with this system are Class III and therefore there may be some devices that require reclassification.

13.	Continuous use definition may affect classification

	The definition of continuous use has been expanded to include situations where the use of a device is ceased and then restarted using the same or identical new device.

14.	(Long awaited) European Databank

	A databank, accessible by all authorities is mandated to be operational by 2012 to store information about clinical investigations, registration, certificates, AR, and vigilance information.

When to Start Applying Changes We have highlighted major changes to the MDD, but as part of the due diligence process, we encourage all our customers to review the revised MDD in its entirety to better assess impact to your business and ongoing regulatory compliance.

A full description of the changes can be found in new directive itself, a copy of which is available at:

http://64.233.183.104/search?q=cache:hu 1PCEbu8w8J:eur-lex.europa.eu/LexUriServ /LexUriServ.do%3Furi%3DOJ:L:2007:247:0 021:0055:EN:PDF+2007/47/EC&hl=en&ct= clnk&cd=1&gl=uk

If you have any questions regarding how a revision in the MDD may apply to your product or your UL audit, please contact your local UL representative or email us at Inform.NB@uk.ul.com.

The changes become mandatory in March 2010. All too often these issues are left until the last minute only to find everyone else is trying to engage their notified body at the same time to get changes assessed and approved. As a Notified Body, UL therefore urges you to take action now to ensure we can work alongside you well before the deadline for your continued compliance and certification with Directive 2007/47/EC on Medical Devices.

Some of the changes will require significant effort by you to implement and other changes are less onerous — however it is important that all changes are addressed soonest.

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