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Under the Codex4SMEs - the support programme for diagnostics manufacturers, Med-Di-Dia Limited is offering 2 FREE workshops for Diagnostics Manufacturers. 

 

Find the details about - Online Training: Quality Management System (QMS) / ISO 13485:2016 Workshop

 

 

There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requirements on Legal Manufacturers whose devices will be re-classified (devices higher than Class A) due to the rules associated with these changes.

 

This workshop will include:

• What is device classification (list of devices and classification code)
• QMS function and ISO 13485:2016 impact
• What do clauses 4 to 8 mean within the scope of ISO 13485:2016 and how do they apply
• Internal Assessments and Notified Body relationships

In order to avail the benefit of this workshop, the companies need to be eligble under the following crieteria:

• Check your eligibility:
  • Does your company meets the SME definition of the EU?
  • Did your SME receive more than a total of €200.000 of de Minimis state aid between 2020 and 2022? For more information about de-minimis aid. You can find helpful information via these links  de minimis rule and state aid.
• Before you apply, read the full Business Growth Programme description
• Select only one of the two services provided by Med-Di-Dia you want to apply for by June 3rd, 2022.

After checking the eligibility, Companies should:

• Complete an application form and
• Submit your application and your de minimis self-declaration

 

For more information Click here or send an email at mdd@mddltd.com