Ask a Question

The partners and associates are excited to announce a new feature that allows you to pose a question for discussion. Each week we will pool our expertise and answer.

You can browse the question and answer archives, forward one to a colleague and even submit feedback yourself. We will look forward to many interesting discussions on regulatory, product testing and quality management system issues.

If you ask a really good question we will even get some of our colleagues such as EU competent authorities, regulatory inspectors or notified body technical managers to give their views as well.

You will want to bookmark this page as the discussion changes each week with new questions/answers, feedback, examples and links.

Ask a question

This Month's Question:

When do we need to have a copy of an international standard available?

Answer: Most regulatory inspectors and notified body assessors will
require you have any standard, guideline or reference document that
you claim compliance with readily available. The logic is simple, how
can you claim compliance when the document specifying requirements is
not readily available to you. The document can be downloadable from
the web (electronic) or held by you in the traditional printed version. You also need to have a process for reviewing changes, new editions, amendments, errata, etc. when they become available.

As a final point, cost has rarely been the primary factor in selecting
a notified body.

Previous Questions:

Do you have any suggestion on selecting a notified body?

Answer: The Group has been in operation for over fifteen years and in
that time we have had an opportunity to work with many different notified
bodies. While there are many considerations, three always seem to
garner the lion's share of discussion. First, select a notified body
who can provide one-stop shopping. Quality system registration,
product testing and whatever else you require from a single source is
a huge plus. (Makes you a very important client too.) Second, explore
how the notified body handles change. Your product line is very fluid
and no doubt you add, delete or change things frequently. If your
Notified Body has arduous or costly processes you must accommodate
then your expenses and dissatisfaction will quickly escalate. Lastly,
consider how convenient their location is to yours. Multiple time
zones, travel expenses and translation issues all seem to come up at the
most inopportune time.

As a final point, cost has rarely been the primary factor in selecting
a notified body.

What do notified bodies do when a product has more than one directive which applies to it?

MD, California

Our answer... Generally Notified Body technical managers are keenly aware of the directives. For medical devices in particular all pertinent directives have to be complied with prior to CE Marking. During the risk assessment work you should review the directives for applicability and where they do not apply include a rationale. From time to time a product will be CE Marked (sometimes for years) and then a new requirement is noted. Manufacturers are advised to be very vigilant as it is usually your competition that brings your non-compliance to light.

"Has 'ISO 15223-1:2007, symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General Requirements' superseded 'EN 980:2003, Graphical symbols for use in the labelling of medical devices?'

Chris Pereira, Vice President of Operations, MedStent Inc.

Our answer... Unfortunately no, EN 980:2003 is the harmonized European Norm for all medical device directives. If you CE Mark your product compliance with the requirements of EN 980 is mandatory and your notified body will seek objective evidence as part of their quality system registration and surveillance assessments and/or design dossier reviews. ISO 15223 may very well supersede EN 980 and even the FDA is giving it very serious consideration, but for if you export to Europe you will need to comply with EN 980.