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As a medtech lawyer, my focus naturally gravitates to assessing “downstream” relationships and risk; that is, analysis of the legal arrangements between manufacturers, distribution agents, and health care providers that together bring medical technologies to the patient’s bedside. These relationships can be complex, as are the legal issues they raise. But ensuring ethical standards in these relationships […]

It is important that the medical technology sector functions within a healthy ecosystem. Our sector needs an environment that is open, supportive and free from unnecessary bureaucracy in order to innovate and provide patients safe and effective solutions to their condition. Within the product lifecycle of a medical technology product, we work with patients, doctors, […]

The year 2016 is just around the corner. While there are still weeks before we say goodbye to 2015, I’m going to write a few thoughts on what I think will be the key themes for the medical technology industry next year.  I did a similar blogpost last year and I’ve done another round for […]

At W.L. Gore we took the decision to review our educational strategy well before the recommendation of the EDMA and Eucomed Boards to phase-out direct sponsorship of Healthcare Professionals (HCPs) to third party organised educational events was announced. We did this as our business leaders were getting increasingly concerned about the complexities of doing business […]

In my view, a good legislation needs to be clear and feasible. A regulation that breeds complexity doesn’t help anyone. The medical device discussions are coming to an end with the current trilogue discussion between the European Council, Parliament and Commission. While we welcome the general direction of this regulation, I worry about the unnecessary […]

With the summer holidays well and truly behind us, and temperatures outside gradually dropping, I am sure the temperature inside the EU institutions is rising as the EU machine is picking up steam again. Commission portfolios have been handed out, the Commissioners-designate will soon be vetted, and certain competences are being moved from one Directorate-General […]

We’re right in the middle of a year of change in the EU. Europe has begun voting and EU politics may look quite different as a result. New things and new faces may be on the horizon but that doesn’t mean that work has stopped on a file of great importance to the Union’s more […]

For the first time in West Africa, a case of Ebola was confirmed on 21 March, three weeks after the first alert of a possible viral haemorrhagic fever emerged from Guinea’s Forest region. Animals such as fruit bats, rodents and monkeys, abundant in the adjacent rain forest, are believed to have served as ‘reservoir’ for the virus. However, once it passed from an infected animal to a human-being, the virus is now ready for human-to-human transmission. Though frightening and very lethal, relatively simple precautions can break the cycle of transmission and stop the epidemic from spreading. Dr Jean-Louis Mosser (JLM), health expert from the European Commission’s Humanitarian Aid and Civil Protection department (ECHO), is in the Guinean capital, Conakry, where he has been participating in crisis meetings and guiding ECHO’s response. He gives us a state of affairs.

The revision of the IVD and MDD Directives has ensured that the last quarter has been a really colourful, hectic and interesting one. The revision process has now entered a new phase where Council will need to agree on a position, after which it will have to negotiate this position with Parliament. That negotiation should then lead to the final texts for IVDs and devices. In terms of timelines, the Parliament is set on finalising both processes before the European elections of May 2014. Until then, I’m sure the evolutions will provide me with plenty to blog about.