European Union Regulatory Update, January 2011

(Published January 2011)

We write to bring you several updates on the EU regulatory landscape. The European Union’s regulatory community appears to be a flurry of activity with new MEDDEV guidance, updated standards lists, and a newly released roadmap for the much anticipated recast.

New Standards List Published to OJEC

On January 18, 2011, an updated list of standards (considered European norm harmonized to the directives) was published in the Official Journal of European Communities (OJEC). Each directive has a corresponding list of applicable standards. Of particular interest are standards on the MDD, IVDD, and AIMDD.

According to each of the directives' Article 5 provisions, compliance with European Norm standards harmonized and published in OJEC presumes compliance with the relevant Essential Requirement. (Of importance, EN ISO 14971:2009 remains the version of the risk assessment standard which is considered harmonized and published in OJEC.)

MEDDEV Guidance on Reporting Adverse Events During Clinical Investigations

The European Commission has issued new MEDDEV guidelines for reporting serious adverse events that occur in the course of clinical investigations.

The new guidance document, MEDDEV 2.7/3,[1] addresses the requirements of Directive 90/385/EEC, Annex 7, and Directive 93/42/EEC, Annex X, which (as amended by Directive 2007/47/EC) specifies that, “All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.”

Although the amended language of Directive2007/47/EC was an improvement over the original directives’ wording, it still left many gaps in the expectations for fulfilling this requirement. MEDDEV 2.7/3 clarifies the following major points:

Which events should be reported
Who is responsible for reporting events
Who should be notified of events
Timelines in which reports should be made (clarifying the word “immediately” in the directive)

The scope of the guidelines apply to non-CE marked devices and CE-marked devices being tested for applications beyond the uses for which the CE mark was initially ascribed.

The guidance also offers a template to be used for reporting adverse events to NCAs. The guidance suggests making submissions in Excel format. An Excel template is available from the EC website.[2]

The new guidance is a welcome addition to the MEDDEV ensemble, outlining a clear scope of the requirement for reporting adverse events in clinical investigations and offering much needed clarification on several points of confusion. This guidance should assist industry in complying with directive mandates and avoiding wasting resources on unnecessary reporting.

EU Recast Update

The EU Commission has committed to a Recast of the MDD and AIMDD in order to simplify and strengthen the regulatory framework, fill gaps in addressing new technologies, and move closer to global models.

A proposal is expected in the first quarter of 2012. To this end, the EU Commission has recently published a roadmap for progress on the intended recast.[3]

The recast is expected to have far-reaching implications throughout the medical device and regulatory industries. The roadmap offers a glimpse into what can be expected when the recast is implemented and an opportunity to prepare for the inevitable changes ahead.

Suggestions for a Regulatory Webpage

Finally, every year we like to encourage our clients to consider creating an online international regulatory compliance page. If a dedicated regulatory page does not already exist, there are many reasons to do so. Whether your organization already has a regulatory page or is considering creating one, the following example may be helpful:

www.emergogroup.com/sample-regulatory-compliance-web-page

We recommend this type of web page because listing your certificates, clearances, approvals, and other regulatory compliance information in one location online makes it easier for customers, end-users, distributors, and regulatory officials to establish contact to request more product information (or report an incident). It also highlights the organization’s dedication to quality and safety since you are proactively demonstrating compliance with international regulations.

We hope the New Year is off to a good start and wish you all the best until the next time!

Regards,