Jun 15, 2011

Several initiatives to improve the business and regulatory environments in the EU medical device sector are underway that could impact most medical device manufacturers doing business in the region. Additionally, an updated list of Harmonized Standards has been published in the Official Journal.

New Standards List Published to OJEC

On May 13, 2011, an updated list of standards (considered European norm harmonized to the Directives) was published in the Official Journal of European Communities (OJEC)—the second update this year. 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.

Most notably, EN 15986:2011, Symbols for Medical Devices Containing Phthalates, has made its long awaited debut in the list of harmonized standards for medical devices. This standard provides a framework for manufacturers to comply with the requirements of Directive 2007/47/EC on Annex I, section 7.5.

Notified Body Code of Conduct

In order to address the longstanding concerns about disparities in quality and performance between the Notified Bodies in the EU, and because of the perceived slow pace of the Commission to address these issues, several of the leading Notified Bodies have voluntarily signed a Code of Conduct for Notified Bodies.

The Code of Conduct was drafted collaboratively by a group of Notified Bodies, and addresses issues such as qualifications of Notified Body personnel, rules on conduct of work and commitment to patient safety, and guidelines for harmonization between Notified Bodies.

The Code of Conduct, in its entirety, is available online.

Council Conclusions on Medical Device Innovation

On June 6, 2011, the Council of the European Union issued conclusions on the 3095th Employment, Social Policy, Health and Consumer Affairs Council Meeting covering innovation in the medical device sector.

The council recognized the need for a balanced regulatory environment to protect patients and foster innovation in industry, and the need for greater regulatory unity among the EU states.

The council backed some of the major proposals previously discussed as part of the Recast, including updates to IVD classification rules and a centralized database. Notably, the council also discussed some of the issues concerning Notified Bodies that the Code of Conduct of Notified Bodies addressed as well the conclusions presented at the EU Commission High Level Conference (22 March 2011).

Complete text of the press release is available: click here

EC Draft Regulation on e-Labeling Medical Devices

The European Commission has publicly issued draft regulations on electronic labeling (e-labeling) as part of their WTO Technical Barriers Trade activities. According to the EC Notification description:

The draft Regulation sets out conditions according to which instructions for use in paper form may be replaced by electronic instructions for use. It limits the possibility of providing instructions for use in electronic form to defined medical devices and accessories intended to be used in specific conditions. Furthermore, it contains a range of procedural safeguards. Thus instructions for use have to be provided in paper form on request, and a specific risk assessment by the manufacturer and information on how to access to the instructions for use is needed.

The draft Regulation also sets up a few basic safety requirements for:

•   instructions for use in electronic form which are provided in addition to complete instructions for use in paper form, and

•   websites containing such instructions for use.

It is expected that the draft will be reviewed in the Fall of this year. When implemented, the regulation may offer opportunities for manufacturers of particular categories of medical devices to provide non-hardcopy Instructions for Use (or IFUs) by other mechanisms.


  • Stewart Eisenhart