Notified Bodies are organizations accredited by national EU competent authorities with the aim to support the manufacturer in carrying out conformity assessment procedures and issuing conformity certificates, supporting the manufacturer to affix the CE marking to his medical devices. Such conformity procedures and certificates are required under the “New Approach” Directives for medical devices – MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC.
Under these Directives, Notified Bodies should posses the highest degree of professional integrity and technical competence, ensure professional secrecy and be free of inducements – in other words promote high technical and ethical standards in their functions.
With the recent adoption of the new proposals for medical device regulations, the power invested in them by the CAMD (Competent Authorities for Medical Devices) has grown (e.g. unannounced visits) and with them their respective tasks and responsibilities (e.g. scrutiny procedure, minimum requirements to be met by Notified Bodies, minimum content of a certificate issued by a Notified Body and more).
Dr. Peter Ruys, Obelis Senior Regulatory Expert, provides an insight on some of the most important elements to verify with a Notified Body before initiating with him a chosen conformity assessment:
- Have you signed the Notified Body Code of Conduct (see publication on Notified Body Code of Conduct)?
- Explain the scope of your accreditations?
- Demonstrate the qualifications of your auditors (e.g. credentials, experience, etc.)?
- Demonstrate the qualifications of the reviewers of the technical files?
- Demonstrate the program of the last training of your auditors & reviewers?
- Present your international offices and what are the audit terms in case you do not have an office in a specific country?
- Demonstrate your international recognition – are you recognized by the US FDA, Taiwan FDA, Australian TGA, etc.?
- In which language will you require the Technical File to be?
- Demonstrate your requirements in reference to the designation of a European Authorized Representative , what are your minimum requirements?
- What is your position towards the new proposals for medical devices, 2012.541 & 2012.542?
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