A properly-structured medical device technical file is essential for guaranteeing the protection and effectiveness of the products.
(d) a list of the harmonised expectations utilized in entire or partly the references of that have been posted in the Formal Journal of the eu Union or Intercontinental or countrywide benchmarks referred to in Articles 13 and fourteen […]
You need to at the very least be by your layout verification system so that you can post a superb 510(k). You ought to have collected more than enough proof from this method to support the requirement of “substantive equivalence.
Sources: Our content are penned in part dependant on publicly out there facts, and our individual useful knowledge relating to product or service compliance. These are generally several of the primary sources we use:
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And not using a centralised, Technical File automated method of doc and Model Manage you chance generating issues that could cost you time and money.
Why it’s needed: Makes sure that sterile devices keep on being Secure to be used, protecting against contamination or degradation in the device.
Why it issues: The technical file is essential for regulatory submissions and marketplace approval, which include CE marking and UKCA marking.
Having said that, Remember the fact that a maker is not necessarily the manufacturing unit owner but the corporation which owns the model or has established the design.
declare the conformity in their merchandise, by issuing the EU declaration of conformity referred to in Short article 19“
So, how can the people that deal with medial technical file submissions daily, prepare their technical documentation for audit?
There exists not a definitive list of products that need technical documentation. This depends completely within the applicable directives and laws. Generally speaking although, it may be mentioned that the following solutions needs to have technical documentation:
Most importers and producers have already got numerous of such files as section of their product or service requirements, Even though not essentially organized as technical documentation for compliance needs.
Just before a medical device might be legally offered, its technical file have to be geared up and submitted as Element of the conformity evaluation method. The file is essential for demonstrating compliance with related regulatory needs, including the European Medical Device Regulation (MDR).