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,
Vigilance
· 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.
