Application of MDR requirements in place of the corresponding requirements of the Directives according to Art. 120 sec. 3 MDR

According to the Art. 120 sec. 3 of the Regulation (EU) 2017/745 (MDR), device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to the Regulation requires the involvement of a notified body, or device which has a certificate that was issued in accordance with or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, shall meet requirements of this Regulation relating to:

  • post-market surveillance,
  • market surveillance,
  • vigilance,
  • registration of economic operators and devices

which shall apply in place of the corresponding requirements in those Directives.

Therefore, during the MDD and/ or QMS-MD audit of the manufacturer whom the art. 120 sec. 3 of MDR is applicable for, Audit Team shall verify the conformity of the manufacturers QMS-MD and/ or device with the following requirements:

Post-market surveillance (PMS)

  • A manufacturer shall establish a PMS system according to Article 83 (all mentioned articles are the articles of the MDR),
  • There PMS system referred to in Article 83 shall be based on a post-market surveillance plan according to Article 84,
  • Manufacturers of class I devices shall prepare a PMS report according to the Art. 85,
  • Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) according to the Art. 86,
  • Manufacturers shall upload reports to the electronic system on vigilance and on post-market surveillance according to the Art. 92,
  • Technical documentation on PMS must meet the requirements of Annex III of MDR

Market surveillance

  • The manufacturer shall be aware of the market surveillance activities of competent authorities, member states and the commission according to the Art. 93, 94, 96 – 100,
  • The manufacturer shall establish a procedure for dealing with devices presenting an unacceptable risk to health and safety according to the Art. 95,


·         Manufacturers shall report serious incidents and field safety corrective actions according to the Art. 87,

·         Manufacturers shall report trends in accordance with the Art. 88,

·         Manufacturers shall perform an analysis of serious incidents and field safety corrective actions according to the Art. 89,

·         Manufacturers shall be aware of implementing acts according to the Art. 91

Registration of economic operators and of devices

  • Manufacturers shall register their devices in accordance with the Art. 29,
  • Manufacturers, authorised representatives and importers shall be registered according to the Art. 31,
  • Manufacturers shall follow the guidance documents related to the EUDAMED database, e.g. MDCG 2021-1 Rev.1.

Verification of implementation

Audit Team shall verify during upcoming surveillance audits that manufacturers

  • conducted an extraordinary internal audit regarding implementation of applicable MDR requirements,
  • demonstrate an objective evidence of implementation of abovementioned MDR requirements (documents and records),
  • demonstrate competence of the MDR requirements, e.g. MDR Training,
  • conducted an extraordinary management review to verify implementation of abovementioned MDR requirements.