11/05/2007

Obelis European Authorized Representative Center (O.E.A.R.C.)

The Latest EU Regulatory Developments

The new directive 2007/47/EC has implications not only for

manufacturers who sell medical devices in the EU but for the

medical device industry as a whole. The directive amends the

following directives: AIMDD 90/385/EEC, MDD 93/42/EEC and the

directive 98/8/EC concerning the placing of biocidal products on

the market. Manufacturers will need to be aware of several

essential changes in order to ensure compliance with these new EU

regulations.

1) First and foremost, manufacturers are required to designate a

European authorized representative for all classes of medical

devices and the same one for the same category of medical devices

(“single authorized representative”). The authorized

representative is appointed by the manufacturer and deals with the

compliance of devices in relation to the Directives (www.obelis.net)

2) Devices will now be classified by their primary mode of action

and not by intended use

3) Manufacturers of Class I sterile and/or measuring medical

devices will be given the option of using the full quality

assurance conformity assessment module allowing more flexibility

when choosing a compliance route.

4) Software intended for use by the manufacturer for medical

purpose(s) is confirmed as a medical device. Furthermore, if the

software is a stand alone or is incorporated in a device the

validation of the software is required.

5) Clinical data is required for ALL devices regardless of

classification

6) Custom-device manufacturers are subject to a post market

production review system involving incident reporting to the

authorities.

7) Manufacturers must retain their records for 5+ years for the

competent authorities and manufacturers of implantable devices for

15 years for administrative purposes

8) Manufacturers who use third parties to carry out the design and

manufacturer of devices must demonstrate that the controls are

adequately applied to the third party to ensure efficient quality

system operation.

9) Explicit prior authorization concerning conformity and an

assessment of the design documentation is required for Class III

devices to be placed on the market. It is necessary that the

Notified Body reviews the design documentation for the medial

device(s) to ensure proper compliance.

10) All surgically invasive devices intended specifically to

control, diagnose, monitor or correct a defect of the heart or of

the central circulatory system through direct contact with these

parts of the body are classified as Class III devices. The

definition of the central circulatory system has now been expanded

(see Annex X).

11) Regulatory data in accordance with this Directive shall be

stored in a European databank accessible to the competent

authorities. This regulatory data includes information on

registration, vigilance reports and certificates as well as data

relating to clinical investigations. The data should be forwarded

in a standardized format (Article 10b).

12) Devices that use human tissue, blood and plasma will fall

under the scope of Directive 2001/83/EC and will be classified as

Class III.

13) Manufacturers must now clearly indicate the date of issue or

the latest revision of the instructions for use.

14) Manufacturers must provide information on known

characteristics and technical factors known to the manufacturer

that could pose a risk if the device were to be re-used. A

manufacturer's indication of single use must be consistent across

the EU and the information must be made available to the user upon

request.

The new directive modifies several key issues regarding

medical devices and amends three significant medical device

directives. It is important that manufacturers understand their

new responsibilities to guarantee their proper compliance in the

EU. Obelis European Authorized Representative Center (O.E.A.R.C.)

not only serves as an authorized representative for non-EU

manufacturers but also helps make sure manufacturers are as up to

date as possible regarding essential changes to the Directives.

O.E.A.R.C. has had over 19 years of experience providing

superior regulatory consultancy services to manufacturers

worldwide. Furthermore, O.E.A.R.C. is a knowledgeable and

professional source for information concerning this directive and

many other European directives. Obelis’ regulatory experts provide

guidance on compliance as well as assist manufacturers with

important documentation required by the relevant Competent

Authorities and Notified Bodies. To receive a copy of the

Directive, please feel free to contact us at mail@obelis.net.