Canada, EU Experiment with Harmonization

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally published November 1996

James G. Dickinson

They're next-door neighbors in North America, but Canada and the United States are courting the European Union (EU) from different directions on the thorny issue of reciprocal reviews of medical devices. Both countries' regulatory agencies (the Health Protection Branch [HPB] in Canada and FDA here) agree on at least one thing, however: it's early yet, and the European device approval system is still evolving. Actually, so is Canada's, that country having adopted an overhauled device approval system last year that doesn't become fully operational until next year.

None of this, however, deters either HPB or FDA from plunging into novel schemes aimed at harmonizing their approval procedures with whatever system Europe evolves.

In Canada, HPB held yet another meeting with its EU counterparts in October to set up an 18-month series of "confidence-building" experiments. In the words of the chief of HPB's office of legislative and regulatory processes, Don Boyer, the two sides would "exchange information on regulatory requirements, methods of conducting evaluations of products, postmarket reviews, and doing double-blind experiments on evaluating a manufacturer's submission." Boyer acknowledged that industry had not yet been consulted on these ideas, and that in the final analysis, it all would depend on industry's willingness to participate.

"When the time is appropriate," HPB will issue a letter to industry asking for volunteers to submit a bifurcated application for marketing approval in both Canada and the EU. HPB would review such submissions both for Canada and for Europe, and the EU Commission would assign to a notified body the review of the same submissions for the same two markets. Then each side would compare its test work with the other's.

A best-case outcome ultimately would allow applications to be submitted in either Canada or Europe for approval in both regions. The objective would be to save money for both sponsors and HPB.

In Washington, CDRH deputy director of device evaluation Kimber Richter advises that it's not likely that FDA will seek to join in the Canada-EU experiments, but that CDRH is interested in starting a reciprocal-review pilot with the Canadians. This would have Canadian and FDA reviewers sharing the workload on the same application. She believes FDA prefers the harmonization approach, in which countries work cooperatively on building one common set of approval requirements. "That way, whoever does the review, you've got an understanding that you're using the same kinds of criteria," Richter says.

Richter predicts that ultimately the different approaches would come to the same result, "because the notified bodies, if they start taking on different countries' regulations and doing multiple reviews, will pretty soon be seeing where the similarities are, and try to bring them together. It's just not efficient to do four reviews when they can do one comprehensive one."

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.

Copyright© 1996 Medical Device & Diagnostic Industry