The 2022 Notified Body’s survey revealed that many EC Certificates issued under Directive 93/42/EEC (MDD) and Directive 90/385/EC (AIMDD) have expired or are about to expire, but certification under Regulation (EU) 2017/745 (EU MDR) has not yest been completed. There is obviously a gap between the old certificate issued under the MDD and the new certificate based on the EU MDR. Many manufacturers and distributors feel unsure what to do in such a situation.
In this case study, we have summarized our practical experience of bridging this regulatory gap by applying Article 97 of the MDR. Within a month of submission to Swissmedic, our client received a 12 months period, i.e., during this 12 months our clients can continue to sell and work on MDR certification at the same time.
EC Certificate is a must for the sale of non-class I devices
With CE-marking, an EC Certificate is issued to all class IIa, IIb and III medical devices. This certificate usually has a 5-year validity, but many currently valid certificate has a shorter validity due to the MDR transition deadline. The validity of EC Certificate defines the period during which your medical devices can still be placed on the EU market.
After the expiry of the validity of the EC Certificate, manufacturers are no longer allowed to place the devices on the market, however, with the help of the following regulation and guidance, manufacturers have the opportunity to obtain a maximum 12-month grace period for sales until a MDR certificate is issued.
Regulation & guidance for reference
Article 97, EU MDR
MDCG 2022-18
This is MDCG position paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate. This guidance is a subordinate regulatory guidance describing an interim solution for devices that do not comply with the MDR because the old MDD or AIMDD certificates expire before the required MDR certificates can be issued (certification gap).
MDCG 2022-18 sets out how and under which circumstances the competent market surveillance authorities may grant a maximum period of 12 months for the MDR conformity assessment procedure to be successfully completed. During this period, the non-compliant products can be placed on the market. This possibility only exists if the non-compliant products does not pose unacceptable risk to health or safety to users or patients.
MU640_00_001e
This is the Swissmedic Information Sheet – Application of MDCG 20018 in Switzerland. Swissmedic basically adopted MDCG 2022-18. We found this Swiss guidance particularly informative as Swissmedic provides a flowchart to guide manufacturers and CH-REP decide whether the devices in question fall within the scope of Article 97.
Knowledge learned from our own experience
Pre-submission:
a) Only Swiss Manufacturer or CH-REP may file an application to Swissmedic.
b) Swissmedic checks the submitted documents exactly according to the following table of MDCG-2022-18. Therefore, study this table carefully and compile and submit the required documents according to this table structure.
In addition to the documents listed in the following table, Swiss manufacturer and CH-REPs should also provide the following information:
(i) details of the Swiss manufacturer or CH-REP: CHRN, name of company, address, PRRC and contact person.
(ii) list of devices affected by the certification gap including
-
- article number
- device name
- risk class acc. to MDD or AIMDD
- reference to corresponding MDD or AIMDD certificate(s)
- Reference to corresponding Declaration of conformity
(iii) disclosure on notification acc. to MDCG 2022-18 that have been submitted to EU/EEA competent authority by the manufacturer or its EC-REP.
(iv) disclosure of any measures according to Art. 94-97 MDR of EU/EEA competent authorities that have been communicated to the manufacturer, including refusal of periods acc. to MDCG 2022-18.
Submission:
c) The submission in Switzerland should be made via the e-portal Swissmedic eMessage (www.swissmedic.ch/emessage-de).
Post-submission:
d) Swissmedic performs a sample-based review of the submitted documentation in accordance with MDCG 2022-18 with regards to the following criteria:
- no significant changes to the design and intended purpose of the device since 26 May 2021;
- the devices are in transition from the MDD or AIMDD to the MDR;
- the manufacturer’s quality management system (QMS) has met the requirements of the MDR;
- no unacceptable risk to health or safety of patients, users or other persons;
- manufacturers undertaken to continuous application of MDR requirements in relation to PMS, vigilance and market surveillance and proactively inform Swissmedic about any safety related corrective or preventive actions.
e) Depending on the quality of documents submitted, the time from submission to approval may vary, but in our case, it took less than one month.
f) Swissmedic does not issue a new certificate, but a letter of authorization with a maximum duration of 12 months. The duration of the authorization may depend on the risk class of the device and post-market vigilance and market surveillance data.
g) Make sure you communicate and send the letter of authorization to your distributors.
