Classifying a medical device under Regulation 2017/745 (MDR) means taking into account its intended purpose and inherent risks. Like under the old Directive, Class I devices present a low risk to patients and end users. However, the new Regulation has introduced more rules, which can lead to some devices being upgraded to Class IIa, IIb, or even III.
To help Class I manufacturers comply with the new regulation by May 26, the European Commission (2021) has released a useful factsheet. The document shows the necessary steps for compliance in a more immediate and user-friendly way, by summarising the MDCG guidance on the same topic (MDCG 2019-15 rev. 1, 2020).
The nine steps towards MDR compliance
According to the European Commission factsheet, Class I manufacturers should implement the following measures:
● Step 0: Integrate MDR requirements into their Quality Management System;
● Step 1: Prove the intended purpose as a medical device;
● Step 2: Confirm that the device is Class I according to Annex VIII of the MDR;
● Step 3: Demonstrate conformity by:
○ Meeting all applicable general safety and performance requirements set out in Annex I;
○ Performing a clinical evaluation and including it in the technical documentation;
○ Preparing the technical documentation in accordance with Annex II and III of the MDR;
○ Involving a notified body for sterile devices (Class Is), devices with a measuring function (Im) or reusable surgical instruments (Ir);
○ Including safety and performance information in labeling, packaging and instructions for use.
● Step 4: Meet the general obligations for manufacturers set out in Article 10;
● Step 5: Draft the Declaration of Conformity as per Annex IV of the MDR;
● Step 6: Affix the CE mark according to Annex V of the MDR;
● Step 7: Perform the manufacturer and device registration in EUDAMED;
● Step 8: Take the following responsibilities once the device is on the market:
○ Examine the findings of post-market surveillance (PMS);
○ Report all serious incidents and field safety corrective actions (FSCA) to the Competent Authorities, and conduct investigations;
○ Take action if a device placed on the market is defective.
Additionally, while both EU and non-EU manufacturers should identify a Person Responsible for Regulatory Compliance (PRRC), non-EU manufacturers are also required to appoint a European Authorised Representative (EAR) to sell their devices in Europe.
Class I FAQ
On top of that, the document answers 5 frequently asked questions about Class I devices, to clarify deadlines, instructions for use, and language requirements:
1. The transition period for Class Is and Im, and Class I devices upgraded to Upper Class under the MDR will last until May 2024, provided that certain conditions are fulfilled;
2. Class I devices will need to comply with the Regulation by 26 May 2021;
3. Instructions for use may not be necessary for Class I devices, if the manufacturer can demonstrate safe and effective use without them;
4. Labels and IFUs should be provided in the official language determined by the EU Member State, where the device is made available;
5. The MDR also fully applies to medical device accessories.
In conclusion, with this effective guide manufacturers will be able to better understand the MDR requirements, in order to keep selling or start their journey in Europe by focusing on the right priorities.
Tancredi Vergani
RA Department
18/05/2021
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This and all relevant guidance documents are available in our MDlaw Library of Documents.
References:
- European Commission/ (2021. Factsheet for Class I Medical Devices. Retrieved on 18 May 2021 from https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_mdcg_2021_factsheet-cl1_en.pdf?mc_cid=bf897f6732&mc_eid=ac5f508451
- MDCG (2020). MDCG 2019-15 rev. 1 Guidance Notes for Manufacturers of Class I Medical Devices. Retrieved on 18 May 2021 from https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_guidance-manufacturers_en.pdf