Proving that personnel involved in sterilisation are Qualified and Competent

1. Proving that personnel involved in sterilisation are Qualified and Competent Arthur Dunbar

2. The MDR requires evidence regarding the qualification and competency of personnel in sterilization How is the Medical Device industry going to achieve this?

3. Annex VIIRequirements to be met by Notified Bodies 3. Resources 3.2 Qualification criteria in relation to personnel 3.2. 1 The Notified Body shall establish and document qualification criteria and procedures for selection and authorization of persons involved in conformity assessment activities, including as regards knowledge, experience and other competency required and the required initial and ongoing training. The qualification criteria shall address the various areas within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review and decision making, as well as devices, technologies and areas, such as biocompatibility, sterilisation, tissues and cells of human and animal origin and clinical evaluation, covered by the scope of designation.

4. Annex VIIRequirements to be met by Notified Bodies 3.2.2 The qualification criteria referred to in 3.2.1 shall refer to the scope of a notified body’s designation in accordance with the scope description used by the Member State for the notification referred to in Article 42(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description. The qualification criteria shall be defined at least for the assessment of: • The different types of sterilization processes

5. Annex VIIRequirements to be met by Notified Bodies 3.2.5 The personnel responsible for carrying out the product related reviews (product reviews), such as technical documentation reviews or type examination, including aspects such as clinical evaluation, biological safety, sterilization, and software validation, shall have all of the following proven qualifications: • Four years’ professional experience in the field of healthcare products or related activities, such as manufacturing, auditing or research of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.

6. Annex VIIRequirements to be met by Notified Bodies 4.5.3 Product Verification Assessment of technical documentation For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX, notified bodies shall have sufficient expertise, facilities and documented procedures for: • The allocation of appropriately qualified and authorised personnel for the examination of individual aspects such as use of the device, biocompatibility, clinical evaluation, risk management and sterilization and

7. ISO 13485:2016 Clause 6.2Requirements to be met by Medical Device Manufacturers 6.2 Human resources • Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. • The organization shall document the process(es) for establishing competence, providing needed training, and ensuring awareness of personnel. • The organization shall: • a) determine the necessary competence for personnel performing work affecting product quality; • b) provide training or take other actions to achieve or maintain the necessary competence; • c) evaluate the effectiveness of the actions taken; • d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives; • e) maintain appropriate records of education, training, skills and experience (see 4.2.5).

8. Why is this important • The major change is that the Medical Device Regulation is no longer a Directive but a Regulation. • EU Directive: • Applicable to all Member States • Sets certain aims, requirements and concrete results that must be achieved in every Member State • Sets a process for it to be implemented by Member States • National authorities must create or adapt their legislation to meet these aims by the date specified in each given Directive • EU Regulation: • Immediately applicable and enforceable by law in all Member States • As good practice, Member States issue national legislation that defines the competent national authorities, inspection and sanctions on the subject matter.

9. Why is this important • The Regulation on Medical Devices (MDR) and the Regulation on in-vitro Diagnostic Medical Devices (IVDR) went into effect in May of 2017, effectively replacing decades-old legislation and creating new quality and transparency requirements for medical device companies in the European Union. • Although the MDR and IVDR are both technically “in effect,” there will be a transitional period of up to five years for companies to fully comply • The new regulations outline stricter quality requirements as well as enhanced transparency for medical device manufactured or imported to the EU. comply with the regulations.

10. Obligation of notified bodies, medical device manufacturers and contract sterilizers • Do the Competent National Authorities or the Notified Bodies have appropriately qualified personnel who ensure the requirements of the aforementioned regulations are met? • Although the MDR puts the obligation of proving appropriately qualified personnel on the notified body, when the notified bodies audit the medical device companies and contract sterilizers, it would be also be prudent for the medical device companies and contract sterilizers to have appropriately qualified personnel to represent the organization in the audit? • The above mentioned obligations of the Competent National Authorities on the Notified Body will have a trickle down effect and create an obligation on the manufacturer and therefore contract sterilizer

11. Notified Bodies Compliance Challenge With the focus on the sterilisation process, how do the Notified Bodies prove with objective evidence that personnel are • Appropriately qualified in the sterilization technology • Have two years professional experience in the appropriate sterilization technology • Have evidence to prove to the Competent National Authority that your personnel meet this requirement of the MDR.

12. Business Compliance Challenge • As motioned previously The obligations of the Competent National Authorities on the Notified Body will have a trickle down effect and create an obligation on the manufacturer and therefore contract sterilizer • Do you have a person responsible for the Sterilization lifecycle? • Does you’re the person responsible for the Sterilization lifecycle meet the requirements of the MDR and 13485:2016 Clause 6.2? • If the medical device manufacturer or contract sterilizer are audited by your notified body, does the person responsible for the sterilization lifecycle, have the necessary skills and training to respond adequately? • Do you have personnel who verify that your contract sterilizer is providing you with a sterilization cycle and report that is compliant with the relevant sterilization standards or guidelines?

13. Is The Sterilization Industry Prepared • There are a number of Sterilization courses available across the world. • Is the training consistent across the different organisations providing the training/certification? • What evidence is there that the trainer themselves is qualified? • Has the training course been moderated by the specific sterilization industry to ensure it meets the International Standards and current industry practices?

14. What we need to do. • Define core modules that have to be completed for fundamentals of irradiation. • Identify which core modules each organization ie AMMI, NIST, ASTM are proficient in giving training and examination in. • Define further modules required for the specific industry ie Contract Sterilizer, Notified Body Auditor, Medical Device Manufacturer • Define how certification will be managed across member organisations • Define requirements for continued proficiency in the industry • Will a Radiation Sterilization Industry Body need to be created to facilitate cross functional communication and review of training

15. When do we need to do this • Define draft timelines for scoping and contacting initial affiliates • Define initial affiliates • Define draft time lines for review and approval of program • Identify Competent National Authorise we should initially contact

16. Any Questions?