Posted by Peter May 15, 2019 10:13:27
General speakiong, using already existing standards are always better than create something yourself!
Posted by Peter May 15, 2019 10:13:27
Posted by Peter May 04, 2019 13:33:16
Posted by Peter Apr 10, 2019 14:06:48
Posted by Peter Apr 08, 2019 12:22:49
Posted by Peter Apr 03, 2019 14:51:34
Posted by Peter Mar 26, 2019 07:49:58
Posted by Peter Mar 18, 2019 21:31:34
Posted by Peter Mar 14, 2019 08:02:19
To be an EU Authorised representative in the new MDR add many new requirements to be meet. In future posts I will go through these.
In addition to what the role is in MDD the representation means a large undertaking of responsibility. In most corporations this are inhouse task that typical someone at the Quality or Regulatory department have. Going forward this most likely will land at the designated persons desk! What will this mean from a personal risk perspective? Right now no one really knowes! Hopefully the law firm speaking about this at the Regulatory Summit
will shed some light, at least for the people in Sweden. The personal risk will probably differs between countries due to the national view and traditions. Clearly something to make some reasearch about before signing up for the role.
Posted by Peter Mar 12, 2019 13:13:41
FTC, FDA and DOJ, is this how it will work with
the new MDR?
Most people working with medical devices that are sold in USA knows what FDA do and their role in promotion and labelling activities.
Not all people understand Federal Trade Commissions (FTC) role and escaping or handling FDA does not always mean that you are safe! FTC are perhaps more known for approving deals from a competition perspective, but that’s also why they look at advertisement and promotion.
FTCs basic requirements are quite straight forward and can be found on this link. However even though it should be simple to follow many companies get into trouble.
FDA warning letter
Department of Justice, DOJ typical gets involved when FTC or FDA have found issues, A FDA warningletter itself does not mean that you directly get into trouble but often leads to that DOJ looks into the case. If DOJ determine that they can claim money back from companies or hospitals they will act.
A typical case:
In case of warning letters due to promotion or advertisement (often off label claims = not within intended or indication for use) DOJ often can find wrongly assigned reimbursement codes. If they find this they will claim that money back. And trust me, if you think FDA can be difficult to handle in a non-compliance situation, that’s a walk in the park vs DOJ! In the future I will show several cases in the blog.
One example on this!
The connection to MDR?
In the past promotion and advertisement in Europe have been a national regulation if regulated at all for B2B type of transactions. With MDR this change completely, now it will be the law in all EU countries. The rules can be found in article 7 copied below:
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
(a) ascribing functions and properties to the device which the device does not have;
(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
Who will this apply to?
The rules could apply to most economic operators. The manufacturer, importers or distributors are probably the ones that most likely could get into trouble if they do not have this under control. However currently the reimbursement system does not have the direct relation to intended use why the monetary penalties most likely will be tied to harm instead. Enforcement will most likely be on national level due to language used.
Posted by Peter Mar 11, 2019 18:55:26