Navigating the options for ISO certification can be confusing especially if you are a manufacturer who previously self-certified your device but under the MDR (EU 2017/745) or IVDR (EU 2017/746) are now subject to Notified Body conformity assessment. This Q&A will hopefully help to explain the differences, advantages and disadvantages of choosing a Certification or Notified Body for your ISO13485 certification. 

1. Who authorises an organisation to audit and issue ISO 13485 certificates?

An accreditation body e.g. UKAS in the UK. Therefore, both Certification and Notified Bodies are authorised by the same organisation. 

2. What is the difference between Certification and Notified Bodies? 

A Certification Body, unlike a Notified Body are not designated to conduct conformity assessments and issue MDR or IVDR certificates. 

3. Why do I need a Quality Management System? 

Article 10 (part 9) of MDR and IVDR require all manufacturers (regardless of device classification) to have a compliant Quality Management System (QMS). In addition, conformity assessments require Notified Bodies to review a manufacturer’s QMS system. 

4. When is it advantageous to have a certified Quality Management System? 

As a manufacturer of a medical device or in vitro diagnostic medical device that is subject to a conformity assessment by a Notified Body (i.e. all devices except class I or class A), it demonstrates conformity against the QMS requirements associated with MDR or IVDR. 

5. Why would a manufacturer choose a Certification Body rather than a Notified Body? 

Cost, choice, suitability and availability. A Certification Body is likely to be cheaper, with more choice of providers and more readily available than a Notified Body. If the device is not subject to Notified Body conformity assessment an ISO13485 certificate issued by a Certification Body would be sufficient.  

6. What is the consequence of a manufacturer using a Certification Body rather than a Notified Body if device is subject to a Conformity Assessment? 

A Notified Body must perform a review of a manufacturer’s MDR or IVDR QMS as part of a Conformity Assessment. If a Notified Body has already issued an ISO13485 certificate, then there are fewer MDR / IVDR QMS specific requirements to audit. If the manufacturer uses a Certification Body, Notified Body’s do not in our experience accept these certificates as sufficient evidence of meeting all the QMS requirements of MDR / IVDR. Consequently, Notified Body’s conduct a lengthier Conformity Assessment QMS audit which can be more costly to complete, especially if deficiencies are identified. 

7. What about suppliers using a Certification Body or holding an alternative QMS standards e.g. ISO9001? 

It depends on what your supplier is responsible for. If they are a critical supplier or service provider, then evidence of ISO13485 from a Notified Body would reduce the likelihood of additional supplier audits associated with the Conformity Assessment of your medical device. At Advena we held ISO13485 certification covering the provision of Regulatory and PRRC services, issued by a Certification Body and our client had to pay for their Notified Body to perform a Supplier Audit of ourselves. This would not have been needed had, as we do now, held an ISO13485 certificate issued by a Notified Body. 

So how can Advena help? 

We can complete a gap analysis of your existing QMS and then assist you achieve an audit ready ISO13485 compliant QMS. 

Even if you already have an ISO 13485:2016 approved Quality Management System and have either only recently applied or awaiting NB reviews or audits associated with MDR or IVDR certification, you will need to ensure you have a QMS that includes all the Article 10 part (9) requirements.  

If you have a paper-based system or use a Windows based document storage system, have you considered moving to an electronic QMS (eQMS). Activ is a cost effective, easy-to-use option to manage your QMS, that frees up the time of the person responsible for your quality system.  

Please review further information regarding Activ via our website https://advenamedical.com/activ-eqms-software/  

Contact Us 

For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.