FireworksIt’s time for a celebration!

Why? Did the ENVI committee magically produce a proposal that makes a lot of sense, and ahead of time?

Unfortunately  not – we still have to wait and see what happens on 18 September. But you can count on me writing about it. There will be lots of interesting discussions about this on the Advamed (Washington) and  RAPS (Boston) conferences end of September, and of course on the MedTech Forum (Brussels) event early October, all of them very worth your while to visit.

So what are we celebrating then? Well, the Medicaldeviceslegal blog has just broken the barrier of 100,000 visits.

“Big deal”, you will probably think, “100,000 is not that much in the big scheme of things.” True, but it’s like with some other things – size doesn’t matter, but rather what its effects are. Don’t forget, this blog occupies a specific niche by catering to a small community of readers and only covers EU law. Many people tell me the blog has provided a positive contribution to regulatory and legal knowledge in the medical devices field. In any event, it has become very visible in Google searches. I myself hope that I have made a difference and have helped people in their thinking about regulatory and legal issues in EU medical devices law.


As a result of the blog’s success I have been consulted by politicians and authorities in Europe, have many blog subscribers among our competitor law firms and we have had many interesting discussions in the comments sections. Some companies have confided in me that they have incorporated parts of posts on the blog in their SOPs and quality system, which is a great honour of course. Also, the blog has been instrumental in my law firm winning the Golden Hourglass, the Dutch innovation award for law firms among others because it allows my firm to act very internationally for a relatively small boutique outfit and implements a strategy of sharing valuable information for free with everybody to showcase capabilities.

Diversity & crystal ball

I  am amazed by the diversity of readers. The majority of the blog’s readers is from the US, proving my view that there is a strong need for EU medical devices materials for the US audience. RAPS is doing a good job in this respect, with its EU Fundamentals of Regulatory Affairs book, which contains a comprehensive medical devices section. If you read German you cannot do better than the alpha and omega on EU medical devices regulation, the Anhalt/Dieners Handbuch des Medizinprodukterechts, even if it is in need of updating. If you want a good discussion, especially on standards, join the Elsmar Cove Forums –  the best fora (I think) for regulatory discussion in European and other medical devices affairs.

The US aside I have logged readers from more than 100 different countries, which is amazing. If you look at the map below, there are not many countries left in the world where this blog was not read at some point.

Schermafbeelding 2013-09-03 om 20.10.39

I have been wrong on occasions, but in the end turned out to be close to the mark as to end result. I have sometimes predicted that things will happen that didn’t yet, like that the  Commission will do things they still haven’t done (e.g. the unannounced audits package that we are still waiting for). But, in the end, in retrospect my crystal ball turned out mostly accurate and I hope to have provided you with a worthwhile experience most of the time.

So here’s to the next 100,000 visitors

A big hat tip to you, readers, as gracious as I can manage. You make this a worthwhile effort by reading and commenting. Thanks for your interest and thanks for the many positive comments and support, and for spreading the word to your colleagues.

If I am ever missing subjects that are important to you, just let me know. Ideas are always welcome, as we embark on the journey to the next 100,000 visits.