EU Regulatory Updates: July 2010

(Published July 2010)

We are writing to inform you of a few new regulatory updates. Due to the distinct nature of these topics, this email is organized into four headings below:

• The EU medical device web site has moved;
• The issuance of a new list of European standards;
• The recent revision of MEDDEV 2.4/1 (now Revision 9);
• An update on the European Commission Questionnaire which we had previously communicated to Authorized Representative (AR) IVD manufacturers.

EU Medical Device Web site has moved

Finally, in conjunction with the regulatory reorganization of the EU Commission (medical devices within DG SANCO), the medical device web site has correspondingly moved. The new web site can be accessed here.

New Standards List Published to OJEC - compliance thereto presumes compliance to relevant Essential Requirements

Just last week, 7 July 2010, the newly issued list of standards (considered European norm harmonized to the directives) was published in the Official Journal of European Communities (OJEC). To this end, each directive has a corresponding list of applicable standards. The list appropriate to the directive can be referenced here: MDD , IVDD , and AIMDD .

According to each of the directives' Article 5, compliance with European Norm standards harmonized and published in OJEC presumes compliance with the relevant Essential Requirement.

Of importance, EN ISO 14971:2009 is the version of the risk assessment standard which is considered harmonized and published in OJEC. Additionally, EN ISO 14155-1:2009, entitled: Clinical investigation of medical devices for human subjects, General requirements, is also the most current version. As is EN ISO 14155-2:2009.

MEDDEV on Medical Device Classification Revised

MEDDEV 2.4/1 on classification (medical devices only) has been revised. Revision 8, which was issued in July 2001, has now been replaced by Rev. 9 of June 2010. MEDDEV 2.4/1 Rev. 9 is available on the European Commission website here , and also in Emergo Group's extensive Learning Library along with other important documents.

According to the European Commission, MEDDEV 2.4/1 rev 9 "includes information pertaining to the changes I classification resulting from the amending and implementing Directives issued since the last revision of this document in 2001, including derogation of the classification rules in the case of breast implants and hip, knee and shoulder joint replacements and requirements related to devices containing human blood derivatives and medical devices manufactured utilising tissues of animal origin. In addition this guidance document takes account of the changes "that arose from Directive 2007/47/EC which further amends Directive 93/42/EEC and became applicable as from 21st March 2010." We encourage our clients to review the new revision.

Update on European Commission Questionnaire

We had previously communicated to our AR IVD manufacturer clients that the European Commission had published a Questionnaire soliciting feedback regarding an imminent revision of the IVDD. At the time we communicated this information, the questionnaire was not yet available on the European Commission website, but it has now been published on the official website here . Please remember that the deadline for comment submission is 15 September 2010.

Thanks again for your support of Emergo Group. Should you have any questions, please do not hesitate to contact us.

Best regards,

Evangeline Loh, PhD RAC
EMERGO GROUP | Vice President of Regulatory Affairs

P.S. Our Learning Library contains a wealth of information on medical device and IVD regulations, articles, Ministries of Health worldwide and much more.