Regulation (EU) 2017/745 - Medical Device Regulation (MDR)
Impact on the certification process
1. Q: What happens if I do not ask for an initial audit according to MDR?
A: The duration of the EC-certificate of conformity remains at the current expiry date. If the expiry date is before May 25, 2020, the certificate will be reissued until max. 27 May 2024. If the expiry date of the certificate is after 25 May 2020, it will be necessary to apply for initial certification in accordance with Regulation (EU) 2017/745 early enough to ensure certification according to the Regulation before the expiry of the EC-certificate.
2. Q: Will EC-certification contracts with a deadline after May 26, 2020 be changed?
A: The manufacturer must sign a contract change/addition in order to accept the adjustments related to the transitional provisions. If the manufacturer does not agree to this contract change/addition, the EC certificates to the Directive can’t be maintained beyond 26 May 2020.
3. Q: Will the audit cycle change, if we request an initial audit?
A: The audit cycle remains on a 5-year cycle.
Deadlines for changes
1. Q: What is the deadline for submitting significant changes?
A: If it concerns a change in the design of the product or its intended purpose (as referred to in Article 120 of Regulation (EU) 2017/745), the application must be submitted before October 31, 2019.
1. Q: For a class III device, if a manufacturer only holds:
- an EC-certificate relating to the conformity of the quality management system according to Annex IX (excluding Chapter 2) or Regulation (EU) 2017/745, and
- an EC-design examination certificate in accordance with Annex II.4 to Directive 93/42/EEC
Could the device be put on the market after May 26, 2020?
A: No. It is not possible to affix the CE marking to a product and place it on the market on the basis of a mix of the EC-Directive and the Regulation (see Article 11 of Directive 93/427EEC and Article 52 of Regulation (EU) 2017/745).
2. Q: What happens if my quality system certificate is valid until May 27, 2024 and my EC-design examination certificate is valid until June 30, 2022
A: The product may be placed on the market or put into service in accordance with the provision of Article 120 of Regulation (EU) 2017/745, until June 30, 2022. Beyond this date, it may only be placed on the market or put into service, if it is certified in accordance with the provisions of the Regulation.
3. Q: When shall we apply the PMS provisions for Regulation (EU) 2017/745?
A: Companies have time until May 26, 2020 to implement this regulation, which includes post-market surveillance (PMS). But manufacturers can already begin to put these provisions in place. After May 26, 2020, even if the company markets products under Directive certificates (Article 120 of the Regulation), the provisions and procedures relating to the PMS according to the Regulation will have to be implemented.