SBS - The best value in QMS software

Annex XVI Device Transition Timeline under the MDR

#1
Hello, I'm hoping to gain some clarity on the transition timeline for Annex XVI devices under the MDR. We're a US based company currently selling an aesthetic product in the EU, not subject to the MDD. Under the MDR, this would be considered a Annex XVI device, Class IIa. We currently have no MDD certificate or NB. We seem to be receiving conflicting reports regarding our timeline transition to the MDR. We've been told that without a NB issued CE certificate to the MDR, we will not be able to sell our devices in Europe after May 25th, 2020. However, Article 1(2) of the MDR states that the MDR will only apply to Annex XVI devices after Common Specifications are released, which come into force 6 months later. To our knowledge, no CS's are currently available. So, our ultimate question is: are we able to keep selling our device after May 26th, 2020, or do we need to halt EU sales? Thanks!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
From Article 1(2):
The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.

Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.
According to the Implementation Rolling Plan (updated Dec 20 2019), the implementing act for the common specifications for products without a medical purpose (Article 1(2)) is undergoing the formal adoption procedure and final adoption is expected in Q2 2020. This means that they will definitely begin to apply some time after May 26 2020. When exactly?... I think no one knows now. What the above quote also says is that until that (unknown) date, definitely after May 26 2020, if your Annex XVI device falls within the scope of the MDD you must comply with the MDD - but you say yours doesn't.

A$55
 
#3
Hi Ronen, thank you for the link, that's helpful! My interpretation is that we are able to continue selling beyond May 25th, (as we are outside the scope of the MDD) but will likely be under the MDR before the end of the year (6 months from Q2). Thanks again.
 
Thread starter Similar threads Forum Replies Date
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 1
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
K Section 13.6 Annex 1 MDD 93/42/EEC for Glove EU Medical Device Regulations 0
D Is PMCF really a continuous activity per Annex XIV,Part B? EU Medical Device Regulations 5
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
L EN 62368 (In an Annex - M.4.2.1) Secondary Lithium Battery Charging Safeguards CE Marking (Conformité Européene) / CB Scheme 2
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 13
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
Z 21 CFR and Annex 11 mapping document Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
A EU-MDR Annex I Requirement 10.1(d) EU Medical Device Regulations 3
T Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b) EU Medical Device Regulations 2
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
J MEDDEV 2.12/1's new MIR & IMDRF terms & codes (IMDRF Annex) EU Medical Device Regulations 1
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
H Critical Supplier Agreement acc. to NBOG 2010-1 Annex II EU Medical Device Regulations 5
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
T EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) EU Medical Device Regulations 0
M Annex II - Technical Documentation. V&V, Performance and Safety EU Medical Device Regulations 3
S MDR Annex II Design & Manufacturing info - 'Adjuvants' definition EU Medical Device Regulations 3
J IVDR and MDR ANNEX I Requirements Template EU Medical Device Regulations 5
M Annex I - General Safety and Performance Requirements. Precise identity - how provided EU Medical Device Regulations 6
S Class II Medical Device Conformity Assessment Route according to Annex V only CE Marking (Conformité Européene) / CB Scheme 7
F IMDRF opened a Consultation on Annex E & F and the link to ISO 14971 ISO 14971 - Medical Device Risk Management 4
Douglas E. Purdy ISO/IEC 17025:2017 Clause 8 & Annex B ISO 17025 related Discussions 9
W EU GMP Annex XI - What is an "appropriate QMS"? Other Medical Device Related Standards 2
C Annex II EU MDR gap analysis EU Medical Device Regulations 7
W MDR Annex I chapter 23.2 (q) - Information required on the label EU Medical Device Regulations 17
I Formula in the Annex of IEC 61000-4-3 - How is k=7 determined? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
H Meaning of Annex II, excluding point Clause 4 conformity CE Marking (Conformité Européene) / CB Scheme 4
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
N What should be included in the supply contract - Annex 2 list B IVD ISO 13485:2016 - Medical Device Quality Management Systems 6
R Background of Annex X section 1.1d of MDD 93/42/EEC EU Medical Device Regulations 74
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
W IATF 16949 Annex B: CQI Requirements IATF 16949 - Automotive Quality Systems Standard 1

Similar threads

Top Bottom