The MDCG published today well awaited Guidance for Class I manufacturers!
The MDCG enlists tasks to be carried out by a Class I manufacturer to ensure compliance with the MDR:
- Put in place a quality management system and a system for risk management according to Article 10(2) and 10(9).
- Conduct a clinical evaluation in accordance with Article 61, as established in Article 10(3) and Annex XV.
- Conduct a conformity assessment according to Article 52(7). In specific cases (sterile devices, devices with measuring function, reusable surgical instruments) defined in the referred Article, the manufacturer will request the involvement of a Notified Body (NB).
- Draw up and keep up-to-date technical documentation related to devices as set out in Annexes II and III, in accordance with Article 10(4).
- Draw up an EU declaration of conformity in accordance with Article 19.
- Submit the required information to the electronic system for registration of economic operators (Eudamed) and comply with the registration obligation. The manufacturer will use the Single Registration Number (SRN) when applying to a NB for conformity assessment, if applicable and for further accessing Eudamed in order to fulfil its obligations related to registration of the devices.
- Register the device in Eudamed assigning the Basic UDI-DI to the device, as defined in Part C of Annex VI, and provide this to the UDI database together with the other core data elements referred in Part B of Annex VI related to that device.
- Assign to the device and, if applicable, to all higher levels of packaging, a UDI which will allow identification and traceability.
- Ensure that the device is accompanied by the information needed to identify it and its manufacturer, and any safety and performance information relevant to the user, or any other person, as appropriate (Article 10(11)). This information, set out according to Section 23 of Annex I, must be provided in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label will be indelible, easily legible and clearly comprehensible to the intended user or patient.
- Implement a post-market surveillance system in accordance with Article 83 (Article 10(10)) proportional to the risk class and appropriate for the type of device, this includes additional aspects to be taken into account in case of devices placed on the market in sterile condition, with a measuring function or that are reusable surgical instruments. This system will be an integral part of the manufacturer’s quality management system based on a post-market surveillance plan (Article 84), which will be part of the technical documentation specified in Annex III.
- Implement a system for recording and reporting incidents and field safety corrective actions as described in Articles 87 and 88 (Article 10(13)).
- Put measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC3, without prejudice to more protective measures under national law. These measures will be proportional to the risk class, type of device and the size of the enterprise (Article 10(16)).
The MDCG also clarified that all obligations strictly related to Eudamed will only apply when it is fully functional and any updates will be published on the EU Commission webpage.
- Have available a Person Responsible for a Regulatory Compliance (PRRC).
- Designate a sole authorised representative (for non-EU manufacturers), at least per each generic device group, according to a written mandate.
- Upon request, the manufacturer will provide all the information and documentation necessary to demonstrate conformity of the device to competent authorities and cooperate with them on any corrective action.
- The manufacturer should periodically verify whether implementing and delegated acts, common specifications, technical standards and guidelines might be available on the European Commission website
Before placing a device on the EU market, a manufacturer shall demonstrate compliance with the MDR and its Annex I – General Safety and Performance Requirements.
Class I manufacturer will then affix the CE mark in accordance with Annex V and draw up the EU Declaration of Conformity, including all the information required by Annex IV.
For devices placed on the market in a sterile condition, with a measuring function or which are reusable surgical instruments, the manufacturer will apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI which require a NB assessment, limited to critical aspects such as those concerning sterile condition, metrological requirements and the reuse of the device, as relevant, according with Article 52 (7 a, b and c).
Following the MDCG Guidance, Class I manufacturer shall perform the below necessary steps to guarantee compliance:
For Class I devices already placed on the market in accordance with the MDD, the manufacturer will conduct a gap analysis in order to guarantee that all the necessary requirements outlined below are fully completed at the date of the application of MDR.
0) Integrate MDR in the Quality Management System (QMS)
1) Confirm product as a medical device
2) Confirm product as a Class I medical device
3) Procedures before placing on the market
- Meet the general safety and performance requirements
- Conduct clinical evaluation
- Prepare technical documentation (Page 14-16)
- Request Notified Body involvement
- Prepare Instructions for Use and Labelling
4) Check compliance with general obligations for manufacturers
5) Draw-up the EU Declaration of Conformity
6) Affix the CE marking
7) Registration of devices and manufacturers in Eudamed
8) Post Market Surveillance (PMS)
- a) Review experience gained from Post-Market Surveillance
- Non-conforming products
Have a look at the full text of the MDCG Guidance for overview of all obligations.
The MDCG also provided a clarification regarding the old guidance documents (produced under the Directives), unless otherwise updated in line with the MDR, may have only some limited indicative value under the MDR. For the purpose of the MDR, only the text of the Regulation is valid in law and sets out requirements not reflected in the old guidance. Hence, the MDR alone can be relied upon as a legal basis.