2010 update on European regulatory issues

(Published January 2010)

To start 2010, we wanted to take an opportunity to update you with valuable information regarding recent and upcoming changes to EU regulations. If you have any questions, please do not hesitate to contact us.

European Directive 2007/47/EC

As you are well aware, Directive 2007/47/EC goes into effect March 21, 2010. This Directive will affect all medical devices (except IVDs) marketed in Europe. To review the major changes enacted by this revision, see our update on changes made by 2007/47/EC.

By March 21, manufacturers’ devices must be compliant with Directive 2007/47/EC. However, since Directive 2007/47/EC is an amending Directive, it will automatically be assumed that your devices are in compliance after March 21, at which point you will only need to reference the Medical Devices Directive MDD 93/42/EEC, and not both Directives.

Clinical Data

Directive 2007/47/EC imposes Clinical data requirements on ALL devices, including Class I. It also imposes more stringent requirements as to what constitutes "clinical evidence" and mandates stronger enforcement by authorities and Notified Bodies. The definition of "clinical data" is included and the Essential Requirements includes a requirement for Clinical Evaluation according to Annex X, which has been significantly amended. This new requirement should be taken seriously and we highly recommend you review the changes including:

• Annex I, Essential Requirements, added ER 6a. "Demonstration of conformity with the Essential Requirements must include a clinical evaluation in accordance with Annex X."
• Annex X specifically references a Clinical Evaluation report and that it must be documented.
• Clinical Data is defined and included in Article 1 (k): “The safety and/or performance information that is generated from the use of a device.

Clinical data are sourced from:

• clinical investigation(s) of the device concerned; or
• clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
• published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

Important and useful documents include the GHTF SG5/N2R8 August 2007 Clinical Evaluation and the MEDDEV 2.7.1, Rev. 3, December 2009, entitled: Evaluation of Clinical Data. Note, MEDDEV 2.7.1 was just revised, which has better aligned the European guidance with the GHTF guidance document. Recital 8, which is in the preamble of Directive 2007/47/EC, makes the statement “clinical data, even for Class I devices, will generally be required.”

However, the GHTF guidance indicates: “Similarly, it may be possible to use compliance with recognized standards to satisfy the clinical evidence requirements for devices based on technologies with well established safety and performance characteristics.” Thus, the onus is on the manufacturer, to demonstrate that there is sufficient clinical data on their medical devices.

Guidance on Vigilance Revised, MEDDEV 2.12.1, Rev 6

We alerted our clients about the following important revision to the vigilance guidance on December 22, but in the midst of the holidays, we thought it would be beneficial to summarize it again. The European MEDDEV 2.12.1 entitled "Guidelines on a Medical Devices Vigilance System" has been revised. Revision 6 includes minor “technical” modifications to the Incident Report Form, Annex 3. This has been revised to include the following:

• inserts query if the incident is serious public health threat;
• separates “death” from “unanticipated serious deterioration in state of health, serious public health threat” for classification of incident;
• includes one field for device manufacturing date and one field for expiry date, previously one field;
• adds implant and explant dates, for implants only; and,
• adds question about number of similar incidents. The link to MEDDEV 2.12.1, REV 5 on the European Commission web site no longer functions. However, you can find and download the latest PDF version of MEDDEV 2.12-1 REV 6 in our Learning Library.

European Commission Europa Website redesign

We previously informed you of the European Commission Europa website redesign and the changes this has had on links that may be referenced in your documents. As a result of the new design, some links are now obsolete, so it is important that all website links referenced in documents and procedures be checked. As an example, the MEDDEV website has changed to: http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/index_en.htm

Italian Registration Deadline Extended Until March 31, 2010

As communicated in past newsletters, Italy passed a legislative decree in 2007 (Decreto del Ministero della Salute 20 febbraio 2007 and 20 marzo 2007) which requires manufacturers or their designated entities to register their medical devices (except IVDs which need to be notified through a different process) in the Italian Ministry of Health Database, if the medical devices are to be sold in Italy. The registration deadline has been postponed until March 31, 2010 to simplify the database and modify the current expectations of the National Directory. It is also rumored that Class I medical device registrations may no longer be required. We will keep you informed of developments when they become official.

We hope this newsletter has clarified pertinent information, upcoming deadlines, and European regulatory changes. If you have any questions, we hope you direct your inquiries to Emergo Group. We are fully equipped to assist you with any of your quality assurance, regulatory, or other medical device consulting needs.

Kind regards,

Evangeline Loh, PhD RAC
Vice President of Regulatory Affairs
Emergo Group Inc.

P.S. By the way, we have updated our regulatory process charts for Australia, Canada, China, Europe, Japan and the USA, plus created new ones for Brazil, Korea, Mexico and Russia. You can download them here.