This could have a huge impact on the EU market place including the patients, medical device manufacturers (especially the smaller medical device companies), and put jobs at risk, as well.  See the article from Eucamed on a survey they did of medical device companies in Europe to get an idea of the costs involved with these proposed changes.  On 25 Sept 2013 Eucamed said they expressed “…disappointment and strong concern at the outcome of a vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI)….” in their Article titled Rushed deal leaves patient and jobs in second place.

There are several sources I rely on a regular basis to keep up to date on this changing landscape and the next two websites are some of my favorite blogs as they have very reliable information that is on point, sometimes they will even make a predication here or there (with decent odds of being right, but not always) and always helpful for the medical device manufacturer.

The first of the 2 websites I read regularly is Medical Device Academy.  The article provides analysis and interpretation of how the EU took the next step in approving the proposed medical device regulations. This article covers a lot of ground including the EU Commission Press Release about two new documents in relation to Notified Bodies, Eucamed’s Political Positioning, Next Steps in the Proposed Medical Device Regulations Approval Process (important to read), and lastly Why is there a Rush?

The second website I am always checking up on is MedicalDeviceslegal written by a lawyer that works at a boutique life sciences law firm Axon Lawyers located in the Netherlands who is able to keep a really good pulse of the industry and the development of these types of regulations, laws, directives, and such.  He has written many articles on this specific subject and has been following the process closely.  His latest article indicates that the “ENVI vote result worst of all worlds”.   He gives you the bad news straight up.

Other resources I rely on a pretty regular basis that also have articles on this subject are: 

• RAPS Regulatory Focus which has 2 articles for today 26 Sept 2013 on the subject:
• European Parliament Passes Landmark Medical Device, IVD Reform Proposals
• European Commission Strengthens Oversight of CE-Marking Process
• MASS DEVICE article I saw today on the topic but with other related articles from other days:
• EU panel approves FDA-like requirements for medical devices
• Fierce Medical Devices one article I saw today but with other related articles from other times:
• EU committee backs tougher, U.S.-style device approval system

The Federal Register notice (FR Notice) continues with details about the workshop.  The public workshop is free with registration (please register early) and will be held on April 29 – 30, 2013 at the FDA White Oak Campus at 10903 New Hampshire Ave, Bldg 31 Conference Center, the Great Room (room 1503A), Silver Springs, MD 20993. To register for the workshop visit the FDA’s Medical Devices News & Events – Workshop & Conferences calendar.  There is also an option for a Webcast to view the workshop from off-site web facilities.  To sign-up in this way use the same registration link as above but make sure to note that you want to attend via a webcast vs in person.  The contact person for this workshop is Mary Brady, Mary.Brady@fda.hhs.gov who is also involved with the Home Use Medical Device Initiative so this is a good tie-in with that subject as labeling is critical to get consistent for ease of use or Usability (or Human Factors some call it).  Refer to the blog post on the Home Use Medical Device Draft Guidance document that was issued on 12 December 2012 for details about the Home Use Draft Guidance document and also about the Home Use Initiative.

In the background section of the FR Notice for this Workshop FDA indicates “Currently, there are no regulations that explicitly define and describe a standard content and format for medical device labeling. FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error. Also, there is no single available source of medical device labeling for people to view, search, and download for devices that are used in clinical and non-clinical environments. FDA is aware of and concerned with the risk of medical errors that result from lost or inaccessible labeling.”

FDA also conducted a 2-phase research study with Research triangle Institute (RTI) of healthcare professionals in regard to their experiences with medical device labeling, and what they would like to see in a standardized version of device labeling. Key findings from the study helped create an outline for standard content and format for medical device labeling id’ing the most relevant sections.  Also, survey participants asked for a “quick reference guide”  for proper device operation & use.  They indicated that would be more convenient and effective with the option of referring to a more comprehensive form of labeling.

Additionally FDA also conducted a survey of the National Family Caregivers Association (NFCA) on medical device labeling to elicit home caregivers’ experiences with medical device labeling for devices used in the home environment.  Here again is another tie-in with the Home Use Medical Device Draft Guidance document and blog post on this subject.  It is clear this initiative is tied-in with the Home Use Initiative and will help support each of the initiatives.  FDA continues to say in the FR Notice “As more medical devices migrate out of clinical care environments and into patients’ homes, the assurance that devices are being used properly and safely no longer resides with a healthcare professional; rather, the responsibility is with the patient, spouse, sibling, or even children. When medical devices are sent home with patients or are moved from one location to another, the labeling often becomes misplaced, lost, damaged, or discarded, which may result in adverse events or other complications due to misinterpretations and absence of proper labeling.”

Per the FDA FR Notice the workshop will focus on the following topics for discussion

A. Summary of FDA Work on Labeling

1. RTI two-phase research study of healthcare professionals regarding device labeling.
2. NFCA survey of consumers on medical device labeling.
3. Cooperative Research and Development Agreement with Kwikpoint for the development of visual language for device labeling.
4. The Center for Drug Evaluation and Research measures of success with standard labeling and the use of a drug repository.

B. Standard Content and Format of Device Labeling

1. Review the outline for a draft standard content and format of medical device labeling.
2. Current thinking on a standard content and format of medical device labeling.
3. Use of symbols in medical device labeling.
4. Discuss a shortened version of standard medical device labeling.

C. Repository of Medical Device Labeling for Home Use Devices

1. Online access to device labeling.
2. Panel discussions on using an online device labeling site.
3. Discuss the types of devices whose labeling should be on the site.

For additional information on the topic also refer to the RAPS News article on 4 Jan 2013.