Regulatory

Round 2 for the Parliamentarians to sit and grimace about medical matters and especially device regulation. Can’t wait.

When a pioneering surgeon is sat on the same table as an advocate of evidence-based medicine and greater regulatory controls, it’s easy enough to predict that their views might not align perfectly. So it was with the holding of a UK Parliamentary Select committee on medical devices regulation, held last Wednesday.

When medical device regulation reaches you in Malaysia you know it’s time to comply as failure to do so can result in a juicy fine or a holiday in the “big house”, or both. It’s interesting to see their interpretation of effective regulatory requirements adopting a risk-based and evidence-based approach.

The UK Commons select committee on science and technology is meeting tomorrow (Wednesday 23rd May) to explore how to ensure the safety of medical implants before they enter the market, and how best to collect clinical data once an implant is in use, from the perspective of clinicians, patients and scientists.

Consumers union is bent on regulatory tightening and even resorting to print ads in its quest to convince Joe Public that the evil medical device manufacturers are trying to harm him. One wonders whether they have the right objective in mind though because the regulatory regime they might end up with could actually stifle innovation and be more harm to Joe Public than the present set-up.

It’s never far from our pages, yet one could be forgiven for thinking that European policymakers are still, well, thinking about how to proceed with revisions to the European Medical Devices Directive and its implementation. That’s not quite true, and here’s how.

More coverage of the barmy Eurocrats’ recommendations for new EU medical device legislation. There’s nothing like a good scandal to get politicians chasing votes, and imposing draconian new rules might create more problems than the one they’re designed to address.

We can’t even harmonise the spelling of the word harmonize, so what chance of bringing our regulatory processes closer together?

US regulatory agency the FDA issues very public warning letters to companies which are then trotted out around the media so we can all revel in the organisations pain. But would this level of openness be well received in Europe where medical device regulations seem to be in the media’s crosshairs too frequently for the industry’s own good.

When politicians get involved in issues some of us have spent decades involved with, the result is bound to have a few badly thought through components. In the case of the European MEPs they’ve done an acceptable job of identifying the medtech regulatory issues, tinged with a bit of populist reactionary stuff that would serve nobody.

The FDA has chosen attack as its best form of defence this week as it adopts a very aggressively critical stance over EU regulatory failings. It’s a bit rich though isn’t it when data suggesting EU regs are harming patients seems to be thin on the ground.

This week’s View From The Med is available for your perusal here. Like a cow chewing the cud, why not spend five minutes enjoying our sideways glance at the main events of the past week?

Don’t reform medical device regulations as a knee jerk reaction to the PIP scandal, says lawyer. We agree. But metal-on-metal hips might tell us more about what we should be looking for in a regulatory regime.

Fence sitting or balanced view? Must Medtech always be the evil giant in all of this?

Let’s face facts. Medical device regulation is by definition imperfect, however much we fiddle with it. The world’s toughest regulator is apparently a pussycat allowing devices onto the market without such as a by-your-leave. If you believe the so-well-informed media.

European Medical Device Regulatory changes: Eucomed’s John Brennan speaks at Medtec Europe Congress last week.