What to expect from MDR Authorised representatives? Sandra Ferretti Chief Compliance Officer & Public Affairs Director

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1 What to expect from MDR Authorised representatives? Sandra Ferretti Chief Compliance Officer & Public Affairs Director

2 AR Pivotal 4 compliance

3 AR Pivotal 4 compliance Authorized representative PRRC (role not defined) Although, authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. AR is jointly responsible for defective products and must terminate contract in case the manufacturer has not complied with the obligations laid down in Article 10.

4 Minimum qualification Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance. PRRC => Qualifications required to perform the role of Responsible Person.

5 Minimum qualification Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

6 AR Minimum role «Minimum» mandate : Verify that the EU declaration of conformity and technical documentation have been drawn up - appropriate conformity assessment procedure has been carried out by the manufacturer Keep available copy and updates of : - Technical documentation - EU declaration of conformity - certificate, including any amendments and supplements, at the disposal of competent authorities for the period Comply with its registration obligations and verify that the manufacturer has complied with its registration obligations

7 «Minimum mandate» : AR Minimum role Provide competent authority with all the information and documentation necessary to demonstrate the conformity of a device Forward to the manufacturer any request by its competent authority for device sample Cooperate with the competent authorities on any preventive or corrective action taken to eliminate / mitigate the risks posed by devices Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated. Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation

8 AR & Vigilance EUDAMED access?

9 AR PRRC Minimum role

10 AR PRRC Minimum role The AR PRRC should therefore ensure that: The minimum mandate between the manufacturer and the AR fulfils the requirements of the regulations and is signed by both parties.

11 AR PRRC Minimum role The AR tasks as defined in the regulations articles 11., as well as the responsibilities laid down in article 15.3 and in the mandate are fulfilled by the AR. AR PRRC should ensure that the manufacturers PRRC has the appropriate qualifications, and fulfils his tasks according to the regulations articles The manufacturer s PRRC should therefore be different than the Authorised Representative s PRRC, this to ensure the second level verification by the AR PRRC over the manufacturer s PRRC, and avoid any conflicting of interest.

12 AR PRRC Minimum role The AR PRRC is the person who will ultimately decide to terminate the mandate between the AR and the Manufacturer in case the manufacturer does not fulfil his obligations according to the regulations. The AR can have several PRRC (responsibilities to be defined in written). No mention that the AR s PRRC can be outsourced in case of micro and small enterprises... PRRC shall suffer no disadvantage within the authorized representative s organisation Avoid Conflict of interest between AR is to keep client and PRRC to keep only complying clients.

13 AR 2.0 In practice continuously and permanently at the manufacturer s disposal, the single point of contact for Competent Authorities reachable within 24 hours ensure the objectives are met can therefore delegate some tasks / responsibilities. no minimum time required for the manufacturer s PRRC to fulfil his tasks, as long as the tasks are fulfilled Recommended to have a deputy PRRC, so that continuity and permanence will be ensured PRRC or his deputy shall be able to be reached in case of unannounced audit by NB or CA, and to be present within a short time frame

14 AR 2.0 Manufacturer & AR Liability «Sufficient coverage»

15 CONCLUSION AR 2.0 : Verify some key points (labeling, registration obligations, technical file drawn up, declaration of conformity, validity of CE certificate, sufficient financial coverage) Give regulatory updates to manufacturers Liability

16 Thank You for Your Attention!