MDSAP · Expert · 14 min lesson
MDSAP and EU MDR/IVDR - what MDSAP does not cover, MDCG 2020-14 and integrated audit strategy
MDCG 2020-14 (August 2020), Regulation (EU) 2017/745 Annex IX sections 3.3 and 3.4, Articles 15, 61 and 83 to 92, MDSAP AU F0019.1
What you will learn
- Explain the EU relationship.
- Use MDCG 2020-14.
- Plan MDSAP and notified body audits together.
Key takeaways
- An MDSAP certificate is not a CE certificate; the notified body decides under the MDR and IVDR.
- MDCG 2020-14 (August 2020) is non-binding guidance that lets notified bodies use the complete MDSAP report to inform surveillance audits where requirements are similar.
- It does not apply to initial QMS audits or MDR/IVDR unannounced audits, and yearly surveillance continues (Annex IX 3.3, 3.4).
- MDSAP does not fully cover clinical evaluation, PMCF, authorised representative, EU UDI, financial coverage, PRRC, records control, risk management, vigilance and PMS.
- Plan one calendar, keep a gap list with owners, share complete reports and use one corrective action record for findings relevant to both streams.
Free practice question
Pelham's MDSAP audit ended with no nonconformities, and the sales team announces that the company is now cleared to CE mark a new implant.
What is the correct view?
An MDSAP certificate is not a CE certificate; a notified body conformity assessment under the MDR is still needed.
Correct. MDR conformity assessment is performed by a notified body, and MDCG 2020-14 only lets it consider MDSAP reports in surveillance.
MDSAP replaces the notified body for all devices.
Not quite. MDSAP is a regulatory audit program for five countries; the MDR still requires notified body involvement for many devices.
CE marking is automatic after any ISO 13485 audit.
Not quite. ISO 13485 certification alone does not give CE marking; MDR conformity assessment under the annexes is required.
Only Class I devices need a notified body.
Not quite. MDR Annex IX applies to devices of higher classes, and Class I self-certified devices are a narrow case.
Key terms
- MDCG 2020-14: Guidance of the Medical Device Coordination Group (August 2020) on how notified bodies may use MDSAP audit reports in surveillance audits.
- notified body: The conformity assessment body designated under the MDR or IVDR that issues EU certificates.
- surveillance audit: Periodic audit after certification; under MDR Annex IX section 3.3 at least every 12 months.
- unannounced audit: Audit without prior notice; the notified body performs one at least once every five years (MDR Annex IX section 3.4).
- gap list: A list of requirements not fully covered by MDSAP, with owner, evidence and internal audit date.
- PRRC: The person responsible for regulatory compliance required by MDR Article 15.
Official sources
- MDCG 2020-14 Guidance on the use of MDSAP audit reports in the context of surveillance audits carried out under the MDR and IVDR (European Commission)
- Regulation (EU) 2017/745 Annex IX, Chapter I section 3 (surveillance and unannounced audits)
- MDSAP AU G0019.3 Medical Device Regulatory Audit Report Form Guidelines (FDA)
- MDSAP Frequently Asked Questions (FDA)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.