Applications pursuant to Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746 for a derogation from the conformity assessment procedures
The legal basis for initiating a procedure for authorising the placing on the market and putting into service of a medical device that is non-compliant with Regulation (EU) 2017/745 is laid down in Article 59 of the relevant Regulation. It provides that, by way of derogation from Article 52, any competent may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety or health.
In December 2022, the Medical Device Coordination Group (MDCG) adopted guidance MDCG 2022-18 “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”, which refers to so-called “legacy devices” for which the non-issuance of a certificate under Regulation (EU) 2017/745 does not pose an unacceptable risk to the health and safety of patients, users or other persons, or to other aspects of public health protection. The document is available at mdcg_2022-18_en_1.pdf (europa.eu).
We suggest that stakeholders examine the possibility of applying Article 97 of Regulation (EU) 2017/745 as outlined in the document.
The structure and format of the application for a derogation from the conformity assessment procedures referred to in Article 52 of Regulation (EU) 2017/745 is not specifically prescribed. For preparation of the application for such derogation follow guidance bellow and take into consideration the criteria that JAZMP uses on its decisions on granting derogations from the conformity assessment procedures.
- with the consent of the manufacturer: Authorised representative
- with the consent of the manufacturer and the authorised representative: Importer, distributor
- CE-marked devices under MDR: for a purpose other than certified, under conformity assessment procedures with NB for a purpose other than certified,
- without CE marking under MDR:
- in the process of conformity assessment procedure at notified body, but the procedure is not yet complete,
- with CE marking under MDD, even if the certificate has expired.
- device not CE-marked under the Directives or if the devices are not yet under the MDR conformity assessment procedure.
NOTE: The compassionate use of a medical device is not defined in the legislation applicable to the Republic of Slovenia and has no legal basis in Regulation (EU) 20174/745 or Regulation (EU) 2017/746.
- submitted in the Slovenian language,
- sent by regular post to the Agency for medicinal products and medical devices of the Republic of Slovenia, Slovenčeva 22, 1000 Ljubljana (JAZMP does not have a system for electronic receipt of applications),
- should include the following information and supporting documents:
- Information of the applicant (business entity submitting the application – manufacturer of the medical device, authorised representative of the manufacturer, importer, distributor, contact persons and contact details, etc.),
- the proposal for granting a derogation from the conformity assessment procedures referred to Article 59 of Regulation 2017/745/EU indicating the specific medical device data,
- the grounds for the proposal,
- information whether the manufacturer or the authorised representative has applied for the application under Article 97 MDR to the competent authority in the MS in which it is established, explanation whether the device is so called “legacy devices” (Guideline MDCG 2022-18: Position paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before issuance of a MDR certificate),
- name and address (registered office) of the device manufacturer, copy of the registration document in the Register of Manufacturers or SRN number (Article 31(2) MDR), proof of compliance with the requirements of Article 8(1) second paragraph of the MDR (use of harmonised standards) – submission of the certificate(s)/accreditation(s),
- the relationship between the applicant and the manufacturer of the device,
- name and address of the manufacturer’s authorised representative in the EU, if the manufacturer has the place of business in the third country (outside the EU),
- name and address of the importer,
- the name and address of the distributor and details of the distribution chain,
- a mandate from the manufacturer or his legal representative to the applicant, stating that the manufacturer of the device has been informed of the intention to place a non-compliant device without the CE marking on the market or put into service,
- proof of payment of the administrative fee of EUR 22,60 to the account No.: 01100-1000315637, reference No.: 11 27650-7111002, indicating the beneficiary of the payment: >>Administrative fee – State Ljubljana<<,
- signed in manuscript by the legal representative of the company acting as the applicant or by an authorised representative, with the appropriate power of attorney (the power of attorney must indicate the scope of the power of attorney, who is giving the power of attorney and until when the power of attorney is valid).
- in Slovene language or a certified translation of the power of attorney into Slovene language,
- scope of the power of attorney – indication for which acts the power of attorney is valid, indication until when the power of attorney is valid, whether it is valid also for service of process.
- trade name and generic description of the medical device concerned, model, purpose,
- risk class,
- GMDN or EMDN (CND), if exists,
- description and information overview of the device: intended use, instructions for use, pictures/diagrams clearly showing its function,
- the number of medical devices to be supplied under the exemption and the list of end-users.
- the demonstrated need for the medical device concerned,
- evidence that there is no equivalent alternative on the market (or equivalent device or other treatment),
- an explanation of how the device concerned differs from others on the market,
- market share, availability of the device.
- that the device is essential for public/ patient health,
- that there are currently no alternatives available for patients requiring this device,
- that the choice of the device concerned is the only appropriate route, considering the risk-benefit relationship.
- certificates, notifications, declarations valid outside the EU (certified copies of documents),
- information on regulatory status in other EU Member States, which other Member States have granted/refused derogation from the conformity assessment procedures or the procedure is still in the process – not yet completed,
- conformity history of the device – whether the device had CE marking, certificates, declarations in the EU before the new Regulation came into force,
- whether the device is intended for certification for the EU market or is already in the process of certification (evidence that the manufacturer and the notified body have signed the contact, and that the assessment procedure is ongoing),
- whether critical parts of the device have already been assessed and demonstrate an adequate level of safety for the user or recipient (patient),
- confirmation of compliance with the general safety and performance requirements for the medical device,
- data on clinical studies, testing, clinical data, clinical evaluation,
- evidence of compliance with European harmonised standards,
- technical documentation demonstrating the safety and effectiveness of the medical device,
- including a risk-benefit assessment focused on the application,
- an indication when certification under the MDR by a notified body is supposed to be concluded.
- Information on any safety reports or vigilance incidents with the device concerned (information from the manufacturer),
- information and details on vigilance: the applicant’s plan for vigilance reports and post-market surveillance or recalls.
- evidence of user trainings (whether training is required, who is the trainee, who trains whom, where and when),
- the opinion of the Medical Ethics Committee,
- other documentation relevant to the specific procedure
The procedure for authorisation a derogation from the conformity assessment procedures referred to Article 59 of Regulation 2017/745 is conducted by the JAZMP in accordance with the General Administrative Procedure Act (Official Gazette of the Republic of Slovenia, No. 24/06 – official consolidated text, 105/06 – ZUS-1, 126/07 , 65/08 , 8/10 , 82/13 , 175/20 – ZIUOPDVE and 3/22 – ZDeb; hereinafter referred to as the “GAP”). In this context, on the basis of Article 140 of the GAP, if deemed necessary the JAZMP may request additional documentation, which does not exclude e.g. the opinion of the Medical Ethics Committee of the Republic of Slovenia, a declaration that the medical device in question will be used under the sole professional responsibility of the doctor, the patient’s knowledge/consent to the implantation of a medical device without a CE mark, evidence of liability insurance for both the manufacturer and the doctor, a follow-up plan for the patient after implantation of the medical device, etc.
Submission of the application and documentation does not necessarily mean that the JAZMP will approve the derogation from the conformity assessment procedures.
DECISION TO GRANT A DEROGATION FROM THE CONFORMITY ASSESSMENT PROCEDURES:
All mandatory criteria must be met for the approval of a derogation from the conformity assessment procedures:
Obligation to fulfil the criteria
The need/clinical necessity is justified
Regulatory approval outside the EU/in another member state
Compliance with relevant standards, certification under directives, manufacturing under ISO standards for medical devices
General safety and performance requirements according to Annex I of the MDR/ IVDR are fulfilled
Clinical data from studies/testing are available to the extent that demonstrates that the device is safe and effective/clinical evaluation
Conformity assessment process by notified body ongoing or the contract is signed
- time limitation to a specific period,
- restriction to users (e.g. to a specific healthcare facility, no supply to other users),
- labelling (on the label – emergency approval – on the smallest possible package of the device),
- vigilance reporting requirements,
- no further changes to the medical device, according to the issued MDD certificate (without change in design and purpose),
- require that a conformity assessment procedure will be carried out and that the device will be placed on the market with a CE marking under the MDR,
- to inform JAZMP of the status of certification procedure under the notified body,
- report on medical devices supplied under derogation from conformity assessment procedures, recall of MDD compliant medical devices supplied after completion of the conformity assessment procedure,
- informing the JAZMP of regulatory developments in other member states,
- notification to healthcare professionals about the granting of a derogation,
- informing the JAZMP when a medical device has acquired the CE mark under Regulation (EU) 2017/745,
- any other requirements.
JAZMP will refuse a derogation from the conformity assessment procedures in cases where at least one of the following grounds applies:
Insufficient demonstration of medical need of the device concerned in the procedure
Identified non-conformities in the technical documentation/ other identified non-conformities in the documentation submitted
Sufficient number of alternatives on the market or existence of other treatment possibilities (pharmacological, surgical,…)
The manufacturer of the device is not registered as a manufacturer of medical devices, does not have an appropriate certificate that manufacturing meets the requirements of ISO standard for the manufacturer of medical devices
The conformity assessment procedure with the notified body has not started yet or no start date has been agreed with the notified body
Insufficient clinical data/absence of clinical studies
Submission of non-authentic/ falsified documents in the application
For decisions in the procedures referred to Article 54 of Regulation (EU) 2017/746 for derogation from the conformity assessment procedures as set out in Article 48 of Regulation (EU) 2017/746, the JAZMP will consider the guidance provided in this document and the same requirements for meeting the criteria for derogation.