The 60601-1 Issues Team today released a DRAFT document (pdf) on EN 60601. 

I asked Leo Eisner, of Eisner Safety Consultants to explain exactly why medical device firms should care about this, thinking I'd get a few sentences. But Mr. Eisner had a ton to say, and clearly emphasized how important this issue is to industry, and the degree of influence the 3rd edition could have on device manufacturing.

This will help push manufacturers to really get a clue. After almost 6 years of the standard being published the EU isn't delaying anymore. Manufactures already got their one chance for a 3-year delay by the EU & Health Canada." —Leonard Eisner

Eisner explains how a query out to stakeholders in June yielded a bigger response than was expected, which shows a lack of clarity when it comes to implementation. 

The key point, says Eisner, is that 2nd ed and 3rd ed of IEC 60601-1 are vastly different. The 2nd ed. has 59 clauses and 3rd ed. has only 17 clauses (when 3 rd ed. was being developed IEC pushed the standard developers to reformat to meet new IEC standards development requirements). Whichever version a company uses, they can't use collateral standards (EN 60601-1-XX) related to 3rd ed. becuase all the other general (EN 60601-1) & particulars (EN 60601-2-XX) used are based on 2nd ed. or vice versa.

Mostly, Eisner emphasizes how critical it is that manufacturers start planning out what they need to do. They need a quality plan, he says. "They may need to redesign product, definitely do gap analysis, update requirements related to risk management, go through testing, and get acceptable results before the end of the applicable transition."

—Heather Thompson