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Regulatory approval process for medical Devices
This document provides an overview of the regulatory approval process for medical devices in the European Union. It discusses key definitions such as the classification of medical devices and relevant EU directives. The approval process involves implementing quality systems, preparing a technical file or design dossier, appointing a notified body for audits and certification, registering the device, and affixing the CE mark. Vigilance reporting and post-market surveillance are also required ongoing responsibilities for device manufacturers.
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Regulatory approval process for medical Devices
- 1. AKSHAY ANAND M IYear – Master of Pharmacy Pharmaceutical Regulatory Affairs JSS College Of Pharmacy Mysuru 570015, Karnataka REGULATORYAPPROVAL PROCESSFOR MEDICALDEVICESINEUROPEANUNION ©2015 akshayanand
- 2. ASPECTS ©2015 akshayanand • Medical Devices–What are they? • European Union – An Overview • EU Directives that impact Medical Devices • Medical Devices as defined by EU • Classification of Medical Devices as per EU • The CE Certification • The Registration Process for MD • The ProcessTimeline for Registration OF THIS PRESENTATION
- 3. 01 • A medicaldevice is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions • It does not achieve its purposes through chemical action within or on the body. • Medical devices vary greatly in complexity and application. • The design of medical devices constitutes a major segment of the field of biomedical engineering. • Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. • The global medical device market reached roughly $209 billion in 2006. ©2015 akshayanand
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- 5. 03 • 28 memberstates plus European FreeTrade Association members. • 24 languages. • Population of more than 500 million people. • GDP of $18.124 trillion. • Euro, the currency equalling 71.47 Indian Rupee per unit. ©2015 akshayanand
- 6. 04 • Medical Devices(MDD) 93/42/EEC • Covers the bulk of medical devices marketed in the EU • Examples: orthopaedic implants, heart valves, medical software ©2015 akshayanand • Active Implantable Medical Devices (AIMDD) 90/385/EEC • Covers devices that require external power sources in order to function properly • Examples: pacemakers, implantable defibrillators • InVitro Diagnostics (IVDD) 98/79/EC • Covers devices used for the examination of specimens taken from the human body • Examples: pregnancy self-testing strips, blood glucose self-testing strips
- 7. 05 ©2015 akshayanand • Personal ProtectiveEquipment 89/686/EEC • LowVoltage 2006/95/EC • Electromagnetic Compatibility 2004/108/EC • Blood Product Directive 2002/98/EC • AnimalTissue Use in Medical Devices 2003/32/EC • HumanTissue Products Directives 2004 & 2005 • Breast Implants Reclassification Directive 2003/12/EC • Hip, Knee, Shoulder Joint Replacement Reclassification Directive 2005/50/EC
- 8. 06 This guidance documentunder Directive 93/42/EEC on Medical Devices provides definition of Medical Devices to include the following: Medical Devices: Guidance Document MEDDEV 2.1/1 APRIL 1994 a. Devices – Accessory b. Medical Purpose c. Customizing d. Medical –Toiletry Purpose e. Aids for Handicapped Persons f. Software g. Multipurpose Products ©2015 akshayanand
- 9. 07 • The classificationof medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. • This approach allows the use of a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness and local vs. systemic effect. These criteria can then be applied to a vast range of different medical devices and technologies. • These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC. Medical Devices: Guidance Document MEDDEV 2.4/1 Rev.8 JULY 2001 MEDDEV 2.4/1 Rev.9 JUNE 2010 ©2015 akshayanand
- 10. • The CEmark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. • The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. • This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. • It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States. • It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. • The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives. 08 ©2015 akshayanand
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- 12. 10 ©2015 akshayanand KEY PLAYERSIN THE CEMARKING PROCESS(REGULATORY APPROVAL PROCESS FOR MEDICAL DEVICES) • Manufacturers and Subcontractors • Competent Authorities • Notified Bodies • Authorized Representatives • Distributors
- 13. 11 ©2015 akshayanand • Competent Authoritiesare entities enforcing Medical Device Directives at the national level in each EU member state. • Member states and their Competent Authorities each have their own interpretations of how Directives should be carried out. • Manufacturers seeking to sell in more than one EU member state should take this into account.
- 14. 12 ©2015 akshayanand • Notified Bodiesare authorized to audit manufacturers’ quality systems and test/review devices for compliance with applicable EU Directives and standards. • Their responsibilities include: • Advising on device classification and ConformityAssessment routes • Pre-assessment of devices • Product and quality system evaluation • Concluding and evaluating manufacturers’Corrective Actions • Issuance of certifications • Maintaining programmed surveillance of devices in the EU
- 15. 13 ©2015 akshayanand • Required forany firm without a location in the EU. • Their responsibilities include: • Liaising between manufacturers and Competent Authorities • Listing their names on clients’ device labels and packaging • Notifying Competent Authorities of manufacturers’ and devices’ names • KeepingTechnical Files/Design Dossiers available for review by Competent Authorities • Participating in vigilance/post-market surveillance procedures EC REP
- 16. 14 ©2015 akshayanand Identify Directives andRegulations appropriate for your device Classify your device according to MDD Annex IX Implement Quality System in compliance with ISO 13485. PrepareTechnical File or Design Dossier demonstrating compliance with MDD 93/42/EEC.
- 17. 15 ©2015 akshayanand Appoint your AuthorizedRepresentative. Have Notified Body audit your Quality System andTechnical File or Design Dossier. Register your device with Competent Authorities if necessary. Prepare Declaration of Conformity and affix CE Marking to your device.
- 18. 16 ©2015 akshayanand • First, determinewhich Medical Device Directive (MDD, AIMDD or IVDD) applies to your device. • Then determine device classification using Annex IX of MDD 93/42/EEC. Class I Non-Sterile Class I Non-Measuring Class I Sterile Class I Measuring Low-risk, non-invasive devices such as non-sterile wound dressings and stethoscopes
- 19. 17 ©2015 akshayanand Class IIa Medium-risk, short-terminvasive devices such as tracheal tubes and lancets Class IIb Higher-risk, often longer-term surgically invasive, sometimes implantable devices including intra-ocular lenses and surgical lasers Class III Highest-risk devices, including all active implantable devices such as replacement heart valves and vascular stents
- 20. 18 ©2015 akshayanand • MDD 93/42/EECAnnex IX contains 18 rules for medical device classification based on factors including the following: • Device’s intended use • Active versus non-active functionality • Device’s duration of contact with patient • Degree of invasiveness • Part of body contacted by device • Special situations
- 21. 19 ©2015 akshayanand • Duration ofContact Criteria • Less than 60 minutes =Transient • Less than 30 days = Short-term • More than 30 days = Long-term • Degree of InvasivenessCriteria • Application to body surface versus an orifice • Surgically invasive or non-invasive • Implantable Determining your device’s duration of contact and degree of invasiveness will help determine how to classify the device.
- 22. 20 ©2015 akshayanand ShortTerm LongTerm LongTerm Transient Transient Medium-Risk Medium-Risk High-Risk Low-Risk Low-Risk Class IIa Class IIb ClassIII Class I Sterile/Measuring Class I Non-Sterile/Non-Measuring
- 23. 21 ©2015 akshayanand Manufacturers of ClassI sterile/measuring, IIa, IIb and III devices must implement quality management systems (QMS) (in compliance with Annex II orV of the MDD). Most manufacturers meet this requirement using ISO 13485.
- 24. 22 ©2015 akshayanand Phase I: Qualitysystem preparation and development • Management buy-in • Assign resources and staff • Conduct gap analysis • Develop quality manual and documentation controls Phase II: Implementation • Employee training • Internal auditing • Corrective and preventative actions Phase III: Registration • Registration audit performed by Notified Body • Final ISO 13485 certification
- 25. 23 ©2015 akshayanand • All ClassI, IIa and IIb device manufacturers must prepareTechnical Files containing data to demonstrate MDD 93/42/EEC compliance. • Class III device manufacturers must prepare Design Dossiers to demonstrate compliance to MDD. • All manufacturers must have clinical data to demonstrate compliance to MDD.
- 26. 24 ©2015 akshayanand 1 Description of productfamily and justification for why your device falls into that family 2 Device intended use 3 Description of device components, specifications, packaging and literature 4 Device manufacturing Process 5 List of accessories to your device 6 Location of design responsibility and manufacturing facilities 7 Classification along with rationale for classification
- 27. 25 ©2015 akshayanand 8 Chosen complianceroute according to applicable Directive(s) 9 Declaration of Conformity stating manufacturer’s compliance with applicable Directive(s) 10 Shelf life and environmental limitations of device 11 Retention of quality assurance, Competent Authority and Notified Body records 12 Vigilance reporting and Medical Device Reporting procedures 13 How and when to contact Competent Authorities 14 Name of and contract with yourAuthorized Representative
- 28. 26 ©2015 akshayanand 15 Subcontractor namesand addresses if applicable 16 Essential Requirements 17 Design input specifications 18 Application and references to Standards and Guidelines 19 Testing results and clinical evaluations 20 Risk analysis 21 Instructions for Use and Labeling
- 29. 27 ©2015 akshayanand • EU regulatorshave increased their requirements for clinical data even for Class I medical devices in recent years. • In many cases, manufacturers must submit Clinical Evaluation Summary Reports that verify the safety and performance of their products along withTechnical Files or Design Dossiers.
- 30. 28 ©2015 akshayanand Manufacturers with nooffices in the EU must appoint Authorized Representatives (EC REPs) to interact with regulators on their behalf.
- 31. 29 ©2015 akshayanand • Registering yourdevice with Competent Authorities before commercialization • Serving as primary point of contact with all EU Competent Authorities • Keeping a current copy of yourTechnical File/Design Dossier available for inspections by Competent Authorities • Authorizing you to place EC REP name and address on your device labels, packaging and instructions for use • Handling Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities • Representing you before the European Commission in the event that your product is withdrawn in a member state • Protecting the confidentiality of your product information • Maintaining reports on clinical evaluation data for review by Competent Authorities • Communicating with Competent Authorities on serious device incidents or FSCAs
- 32. 30 ©2015 akshayanand Following appointment ofyour EC REP, your quality system and Technical File/Design Dossier must be audited by a Notified Body. Upon Successful completion of your audit, the Notified Body will issue a CE Certificate. Manufacturers of Class I Non-sterile/Non-measuring devices self-declare MDD conformity and do not require CE Marking certificates. Class IIa Class IIb Class IIIClass I S/M
- 33. 31 ©2015 akshayanand Class I devicemanufacturers must register with the Competent Authority of the country where their EC REPs are based. Class I S/MClass I NS/NM Class IIa Class IIb Class III Some EU member states do not require registration of Class IIa, IIb or III devices with Competent Authorities. Other countries do not require registration of devices.
- 34. 32 ©2015 akshayanand • In orderto complete the CE Marking process, all manufacturers must prepare a Declaration of Conformity stating their device is in compliance with all applicable Directives. • Upon completion of your Declaration of Conformity, you may affix CE Marking to your product.
- 35. 33 ©2015 akshayanand Product Identification Manufacturer Identification ECREP Information Applicable Directives
- 36. 34 ©2015 akshayanand • EU memberstates MAY require labeling information be made available in their local languages or another European Community language to patients and users in accordance with Annex I, point 13 of the MDD. • All languages subject to subsidiarity All EU member states require device labeling in their official languages Label information in yourTechnical File should only appear in ONE language
- 37. 35 ©2015 akshayanand Source: EmergoGroup.com Device Classification in Europe WaitTime after submission until approval is granted Validity Period for CE Marking Certificate Advance Start Time for Registration Renewal Complexity of Registration Process Overall Cost of gaining Regulatory Approval Class I NS/NM <1 Month No Expiry Not Applicable Class I S/M 3-5 Months 3 Years 2 Months Class IIa 3-5 Months 3 Years 2 Months Class IIb 3-6 Months 3 Years 2 Months Class III 6-9 Months 3 Years 2 Months Simple Complex Low High Simple Complex Low High Simple Complex Low High Simple Complex Low High Simple Complex Low High
- 38. 36 ©2015 akshayanand • PMS requiredfor all medical devices sold in the EU • Manufacturers are required to develop proactive plans for PMS • PMS plans should include reviews of market and field data, complaints and corrective actions • Systematic records of PMS findings must be kept • Purpose ofVigilance Requirements: • Protecting public health and safety • Evaluating incidents to prevent recurrence • Determining effectiveness of corrective actions taken • Monitoring and learning from experience • Vigilance Requirements for Manufacturers: • Establish and maintain systematic procedures to review experience gained from devices in the post-production phase • Implement appropriate means to apply any necessary corrective actions
- 39. 37 • https://en.wikipedia.org/wiki/Medical_device -Wikipedia article on Medical Devices • http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF – Official EU Document : Council Directive 93/42/EEC • http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm - Guidance MEDDEVs Online Directory • http://ec.europa.eu/health/medical-devices/files/meddev/2_1-1___04-1994_en.pdf - Guidance Document MEDDEV 2.1/1April 1994 • http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf - Guidance Document MEDDEV 2.4/1 Rev.8 July 2001 • http://ec.europa.eu/health/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf - Guidance Document MEDDEV 2.4/1 Rev.9 June 2010 • https://en.wikipedia.org/wiki/CE_marking- Wikipedia article on CE Certification • http://www.lne-gmed.com/pdf/en/annex9-directive-93-42-amended.pdf - Official EU Document : Annex IX of Council Directive 93/42/EEC • http://ec.europa.eu/health/medical-devices/faq/market_en.htm - Information about the Medical Device Registration on the Official Website of European Commission • http://medicaldevices.bsigroup.com/en-GB/our-services/ce-marking/ - Information about CE Marking Approval for Medical Devices in Europe • http://www.emergogroup.com/resources/europe-process-chart - Europe CE Approval Process for Medical Devices – Charts &Timelines ©2015 akshayanand
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