General Data Protection Regulation (GDRP)

#1
Hello,

We are looking to market our new product in the EU Class II(a) medical device. I understand the basics if GDRP but what I am having trouble with is figuring out what goverment/agency regulates it. Is there a cerificate issued? If so by whom? Is there a published standard available that can be used to implement a compliant system?

Do we need to have a EU Rep specifical for GDRP?

I would apreciate any help. Our EU rep does not seem to know much about GDRP.

Frank
 
Elsmar Forum Sponsor
#3
Thank you John. So at this point compliance is required but their is no formal regulating body as of the moment and no requirement for EU representation. At least thats all I can turn up so far.
 

John Broomfield

Staff member
Super Moderator
#4
Member counties have their own regulators.

So, if a company sells into the EU but is in breach of the GDPR that company can expect to hear from them.
 
#6
Some are are saying you need an EU rep:

Will the GDPR have any impact on my company if we are located outside the EU?
In the European Union there are around 500 million people and it takes only one to feel their data protection rights are not being respected and take you to court.
If you are located outside the European Union but are serving clients and customers in the EU a data protection representative is a legal requirement and you must comply.

We will support you with being GDPR compliant.

  • Help you copping with GDPR related risks
  • Comply with article 27 (GDPR)
  • Provide safety to your business
  • Use our mail address for GDPR related topics
Make MDSS your GDPR representative in the European Union.

Attached is the EU Reg.
 

Attachments

#7
Looking like an EU Rep is required:

3. GDPR Enforcement in the US
In Europe, enforcement of the GDPR lies with the numerous supervisory authorities in the EEA and Switzerland. However, as the GDPR applies to companies outside of European borders as well, how would the GDPR be enforced in, say, the US?
There are several mechanisms through which the GDPR can be enforced in the US.
  1. If the company has a presence or assets (e.g., bank accounts, real estate, servers) in the EU/EEA, they can be seized for GDPR noncompliance.
  2. For companies without a physical presence in the EU/EEA, the GDPR mandates the appointment of a representative who is physically located within the EU/EEA. In cases of GDPR noncompliance, this representative would be a likely channel through which fines are levied.
  3. International law is another potential channel through which legal action can be taken. Given that it is mutually beneficial for national enforcement agencies to support each other, punitive actions may be pursued by the EU/EEA enforcement agencies. These agencies are likely to be assisted by public agencies in the country where the company is registered.
 
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