Technical documentation - Medical Device Project B.V. · Technical documentation conform Annex II coupled with: ... Cross reference to the location in the TD / STED. 15 ... code,

Technical documentation

Capita Selecta proposed MDR 25-03-2013

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Richtlijn Medische Hulpmiddelen

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Technical Documentation

MDD / AIMDD (In daily practice) technical documentation = design dossier = technical (construction) file = design history file

Summary TEchnical Documentation (STED)

Based on former GHTF guidance, now IDMRF documentation

International Medical Device Regulators Forum

http://www.imdrf.org/index.asp

http://www.imdrf.org/index.asp

MDD / AIMDD – Technical documentation

Contents of Technical dossier defined in: MDD 93/42/EEC: •Annex II.3.2(c) (design of the product – Design dossier) •Annex III.3 (technical documentation) •Annex VII.3 (technical documentation) AIMD 90/385/EEC: •Annex 2.3.2(c) (Design of the product – Design dossier) •Annex 3.3 (technical documentation)

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Proposal MDR – one location

Annex II – Technical documentation (STED?) 1. Device description – specification – variants – accessories 2. Information to be supplied by manufacturer 3. Design and manufacturing information 4. General safety and performance requirements 5. Risk / Benefit analysis and risk management 6. Product verification and validation Annex III – EU Declaration of conformity

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Proposal MDR

Article 7: CTS to be developed to address technical documentation requirements. Article 8: Manufacturer obligation to draw up technical documentation. Article 9: Authorized Representative: Keep the technical documentation available for 5/15 years (!!!).

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Proposal MDR

Article 11: Importer Ensure that technical documentation is drawn up by manufacturer (HOW??). Ensure that the technical documentation is available for 5 / 15 years (HOW??). Article 13: Qualified Person: responsible to ensure TD is drawn up and kept up-to-date. new Liability issue on personal level??? Article 24: Unique Device Identifier: must be included in the TD.

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Article 42 – conformity assessment procedures

Class III: • Annex VIII (Full QA and DD) Or: • Annex IX (Type Examination) and Annex X (prod conf verif.) Class IIb: • Annex VIII, except Chapter II (Full QA) with: “assessment of the design documentation within the technical documentation on a representative basis” – Annex II section 3 only? Or: • Annex IX (Type Examination) and Annex X (prod conf verif.)

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Annex II

Annex III + V

Annex II.3

Annex III + V


Class IIa: • Annex VIII, except Chapter II (Full QA) with: “assessment of the design documentation within the technical documentation on a representative basis” – Annex II section 3 only? Or: • Technical documentation conform Annex II coupled with: • Annex X (prod conf verif.) – Section 7 Part A (production QA) or

Section 8 part B (Product verification)

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Annex II.3

Annex VII+V/VI


Class I – Self declaration on Annex II conform Article 17 (DoC) Class Isterile / Imeasure: • Annex VIII, except Chapter II (Full QA): Or: • Annex X Part A But: NB assessment only on: • Securing / maintaining sterile conditions • Conformity with metrological requirements

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Annex II.3

Annex V

MDR

Article 49: Clinical evaluation:

The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non-clinical testing methods alone, including performance evaluation,

bench testing and pre-clinical evaluation, has to be duly substantiated in the technical documentation referred to in Annex II.

The clinical evaluation and its outcome shall be documented in a

clinical evaluation report referred to in Section 6 of Part A of Annex XIII which shall be included or fully referenced in the technical documentation referred to in Annex II relating to the device

concerned.

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MDR

Article 65: vigilance data: Actively update the TD with this information make available to Notified Bodies. Annex I GSPR 7.5: Phthalate justification needs to be in TD in case device is used for treatment of children or treatment of pregnant or nursing women.

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Annex II Technical documentation

1. Device description and specification including variants and accessories.

STED requirements. But with an EU touch: - UDI - Risk class and rule + justification / argumentation - Explanation of novel features (??? Novel to what?) - Overview previous generations and market experience.

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2. Information supplied by the manufacturer - IFU - Labels (on device and on packaging) New: List of language variants.

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3. Design and manufacturing information (a) Information to allow a general understanding of the design stages applied to the device and the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device. More detailed information needs to be provided for the audit of the quality management system or other applicable conformity assessment procedures; (b) identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed. Remember: Article 42 Class IIa and IIb:

Assessment of the design documentation within the technical documentation on a representative basis

Is this sufficient? Only general understanding? 14


4. General Safety and Performance Requirements (GSPR) • Checklist can be used to demonstrate how the GSPR’s are met.

• As before, but now specifically required to be included: Precise identity of the controlled documents offering evidence Cross reference to the location in the TD / STED.

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Essential Requirements

ER Checklist

5. Risk / benefit analysis and risk management • To address Risk / Benefit as defined in Annex I sect. 1 and 5.

• To identify solutions adopted + result Risk Management as

referred to in Annex I section 2.

In short: EN ISO 14971:2012

EN 60601-1-6 / EN IEC 62366:2008

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6. Product verification and validation • results of verification and validation testing • studies undertaken to demonstrate conformity of the device 6.1 Preclinical and clinical data • results of (engineering, laboratory, simulated use, animal) tests

and evaluation of published literature • Biocompatibility • Physical, chemical and mechanical characterization • Electrical safety and EMC • Software verification and validation • Stability / shelf life • GLP verification

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Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision, e.g. biocompatibility testing on the identical materials was conducted when these were incorporated in a previous version of the device that has been legally placed on the market or put into Service.

Only identical material comparison? ISO 10993-1 requests more!

Maybe better: take risk management approach assessing impact on changes there’s your rationale.

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Also include: • The report on the clinical evaluation in accordance with Article

49(5) and Part A of Annex XIII;

• The PMCF plan and PMCF evaluation report in accordance with Part B of Annex XIII or any justification why a PMCF is not deemed necessary or appropriate.

Already now regularly requested by NB’s to present PMCF Plan

as part of initial submission. Include the results of PMCF activities in the TD.

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6.2 Additional information in specific cases.

• Medicinal product – CTS

• Human / Animal Tissue / cells

• Sterilization validation reports

• Measurement function validation

• Connected to other device evidence of combined use.

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Annex III - DoC

Specifically defines minimal requirements to be included on the DoC: • Name, Trade name etc AND address • Statement: DoC issued under sole responsibility of manufacturer • UDI device ID. • Product / trade name, code, catalogue # etc. • Risk class • Conformity to regulation statement • Reference to harmonized standards / CTD used. • Name of NB and number, conformity route + certificate # • Additional information • Sign, date, place, indication for and on behalf of whom is signed.

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Annex IV

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Conclusion

• If you already follow all current MEDDEV’s, guidances, etc, • If you already have implemented an effective QMS, • If information out of the market is already feeding back in your

dossier through Post Market Surveillance, Risk management, design control,

• What will change, really?

Nothing!

• Although… (changes in rules – classifications, “ER’s” changed).

See you next time!!

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Medical Device Project B.V. Lupinesingel 556 NL-2403 EB Alphen aan den Rijn The Netherlands M +31 (0)6 11880300 T +31 (0)85 2011314 E [email protected] I www.mdproject.nl

We are a flexible and pragmatic team player in your medical device project

mailto:[email protected]

http://www.mdproject.nl/

Documents

Technical documentation - Medical Device Project B.V. · Technical documentation conform Annex II coupled with: ... Cross reference to the location in the TD / STED. 15 ... code,