IVDR Documentation Submissions - BSI Group

1 IVD R Documentation Submissions R ev isio n 3, May 2020 Page 1 of 27 ivdr Documentation Submissions Best Practices Guidelines IVD R Documentation Submissions R ev isio n 3, May 2020 Page 2 of 27 Contents 1 Introduction ..3 2 Submission and technical Documentation Contents ..3 Cover Letter ..3 The technical Documentation ..4 Authorisation for Work to be Conducted ..4 3 Verificat ion of Performance ..4 Information Required to Support Verification of Manufactured Product (Class D O n ly) 4 4 Submission Method ..5 5 Document Language ..5 Electronic F ile Form at an d File S ize L im it 5 Optical Character Recognition (Searchable Format).

2 7 7 P ag in at io 7 Signatures .. 7 6 S u b miss io n Pro 7 Additional Topics to Consider When Preparing technical Documentation for S u b miss io n .. 10 Manufacturer Personnel Support .. 10 Document Availab ility .. 10 10 Certificate Scope .. 10 Sub-contractors .. 10 Accessories .. 11 8 N o velt y .. 11 A d d it io n al C o n sid erat io n s fo r Deskt o p A u d it 11 A d min ist rat ive in fo rmat io 12 APPENDIX B: Reference Documents .. 25 B1. Change Reporting .. 25 B2. Regulatory Guidance O rg an isat io n s .. 25 B3. Specific Topic Gu idance .. 25 IVD R Documentation Submissions R ev isio n 3, May 2020 Page 3 of 27 1 Introduction Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annex es IX to XI of (EU) 2017/746, hereafter referred to as the In Vitro Diagnostic Regulation ( ivdr ).

3 Subject to c lassific at io n , m o st d ev ic es will n eed t h eir technical Documentation assessed by a Notified Body. The technical Documentation submission guidance is aligned to the requirements of the ivdr , described in d et ail in An n ex II an d III. Notified Body BSI (BSI-UK/BSI-NL) and IVD manufacturers both have an interest in speeding up the rev iew of technical Documentation (Summary of technical Documentation (S TE D ), in it ial ap p lic at io n , ren ewal ap p lic at io n , et c .) an d red u c in g t h e t im e t o c ert ific at e d ec isio n . The most frequent reasons for delay s in the rev iew of the technical Documentatio n are: Incomplete Submissions - BSI has not been provided with all the information needed for the rev iew.

4 Poor structuring of the technical Documentation - The information is present within the Tec h n ic al Documentation b u t is d iffic u lt t o lo c at e. To reduce the frequency of the abov e issues, BSI Medical Dev ices Group proposes the following g u id elin es, in fo rm ally kn o wn as IVD R D o c u m en tat io n S u b m issio n s: Best P rac t ic e Gu id elin e . 2 Submission and technical Documentation Contents Three things are required for any technical rev iew: Contex t ( , an ex planation of what is being requested and why ), The technical Documentation ( objectiv e ev idence to demonstrate compliance), Authorisation for BSI to carry out the work.

5 The submission should contain: i. Cov er letter, ii. technical Documentation , iii. Authorisation for BSI to carry out the work. Th ese are d isc u ssed in d et ail in S ec t io n s to Cover Letter The cover letter should contain an executive summary containing at least the following details: Certificate number reference(s) (if known). The ty pe of rev iew (new product, design change, shelf life ex tension, etc.). Brief p ro d u c t d esc rip t io n , in c lu d in g classific at io n (wit h R u le ac c o rd in g t o An n ex VIII), c o n fo rmity assessment route requested, analy tes and technology inv olv ed.

6 BSI Ref. number (Serv ice Management Order (SMO) #) for any other relev ant Submissions (for example, concurrent applications that may affect the submission). An explanation of: What has been submitted and how it demonstrates compliance. IVD R Documentation Submissions R ev isio n 3, May 2020 Page 4 of 27 Fo r c h an g es t o ex ist in g c ert ific at io n : W hat is affected (packaging, material change, life, etc.). What is not affected (along with appropriate justific at io n ). Note: A possible format for this ex planation could be a table based on the sections of the technical Documentation , as b elo w: technical Documentation section A/NA?

7 Description of evidence submitted; for changes, impact on compliance or rationale for why this section is not affected The technical Documentation Th e IVD R is a n ew leg islat io n . Fo r in it ial ap p ro v als, a c o m p let e su b m issio n wit h all t h e relev an t technical Documentation included is required ev en if the dev ice was prev iously certified under the IVDD. To assist manufacturers in determining the correct information to provide to BSI, a comprehensiv e checklist of various documents required to be submitted as part of the technical Documentation can be found in the BSI ivdr technical Documentation Completeness Check form (MDF9003), hereafter referred to as the Completeness Check.

8 Ad d it io n al g u id an c e is also p ro v id ed in Appendix A. Supplementary guidance/information can also be found in the associated reference documents listed in Appendix B. For Submissions in the contex t of scope ex tensions or substantial change approvals, as far as is practical, Submissions should be standalone and not refer to previous Submissions as ev idence of compliance. The rev iewer must be able to assess the Documentation in the contex t of the intended su b m issio n an d c o n firm it is st ill relev an t wit h in t h is c o n t ex t . If a su b m issio n d raws o n in fo rm at io n p rev io u sly su b m it t ed t o BS I, p lease in clude the relev ant report or document which demonstrates c o m p lian c e, rat h er t h an d irec t in g t h e rev iewer t o an earlier rev iew.

9 Ov erall, t h is will sav e t im e ( ., in finding the report , confirming that the correct report has been found, confirming whether there hav e been any changes affecting its relev ance to the current application, etc.). Authorisation for Work to be Conducted A signed approv ed quote will be required before work can commence. If this is not already in place, please contact y our BSI Scheme Manager or BSI Sales Team. 3 Verification of Performance For Class D dev ices (and others, if requested), kits will be required for testing by an EU Reference Lab o rat o ry (E UR L) t o v erify p erfo rm an c e. S c ien t ific Op in io n o f t h e E UR L will b e so u g h t fo r t h e v erific at io n o f p erfo rm an c e c laim s m ad e b y t h e Man u fac t u rer (Art ic le 4 8 (5 )).

10 A p o sit iv e o p in io n will b e n eed ed fo r c ert ific at io n o f t h e d ev ic e. Th is will b e d isc u ssed in m o re d et ail u p o n ap p lic at io n . Information Required to Support Verification of Manufactured Product (Class D Only) P rio r t o t h e v erific at io n o f p erfo rm an c e, t h e E UR L m u st first est ab lish t h e su c c ess c rit eria. Th is will b e c o n d u c t ed in p arallel t o t h e technical Documentation rev iew. Th e fo llo win g will b e req u ired : Batches of product must be sent to the EU Reference Laboratory to establish criteria. IVD R Documentation Submissions R ev isio n 3, May 2020 Page 5 of 27 These batches must meet the manufacturers QC specification and be in the same configuration as the technical Documentation su b m it t ed , wit h c o m p o n en t s c learly lab elled wit h n am e, lo t n u m b er, ex piry date and final draft IFU.