EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 6.1.2023  
COM(2023) 10 final  
2023/0005 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional 
provisions for certain medical devices and in vitro  diagnostic medical devices  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL  
• Reasons for and objectives of the proposal  
Regulation (EU) 2017/745  (MDR)1 and Regulation (EU) 2017/746 (IVDR)2 of the 
European Parliament and of the Council  establish a reinforced regulatory framework 
for medical devices and in vitro  diagnostic medical devices. Their objectives are  a 
high level of protection of health for patients and users and  the smooth functioning of 
the internal market for these products.  To achieve these objectives and, in light of 
issues identified with the previous regulatory framework, the Regulations set out a 
more robust system of conformity assessment to ensure the qu ality, safety, and 
performance of devices placed on the EU market.  
The MDR has been applicable since 26 May 20213. The transition period provided 
for in Article 120(3) will end on 26 May 2024.  
The IVDR has been applicable since 26 May 2022 . In January 202 2, the European 
Parliament and the Council adopted a staggered extension of its transition period , 
ranging from 26 May 2025 for high risk in vitro  diagnostics to 26 May 2027 for 
lower risk in vitro  diagnostics , and to 26 May 2028 for certain provisions con cerning 
devices manufactured and used in health institutions4. 
Despite considerable progress over the past years, the overall capacit y of conformity 
assessment (‘notified’) bodies remain s insufficient to carry out the tasks required of 
them. In addition, many manufacturers are not sufficiently prepared to meet the 
strengthened requirements of the MDR  by the end of the transition period . This is  
threatening the availability of medical devices on the EU market . 
At present, 36 notified bodies are designated u nder Regulation (EU) 2017/745 . 
Further 26 applications for designation as notified body are currently being 
processed; three of them are at an advanced stage5.  
In October 2022, notified bodies reported  they had received altogether 8,120 
applications from manufacturers for certification under the MDR and had issued 
1,990 certificates in accordance with the MDR . According to a n estimation presented 
                                                 
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).  
2 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro  
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 
(OJ L 117, 5.5.2017, p. 176 ). 
3 Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending 
Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its 
provisions (OJ L 130, 24.4.2020, p. 18)  had postponed the date of application of Regulation (EU) 
2017/745 from 26 May 2020 to 26 May 2021 due to the COVID -19 outbreak  and the associated  public 
health crisis . 
4 Regulation (EU) 2022/112 of the European Parliament and of the Council of 25  January 2022 amending 
Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro  diagnostic medical 
devices and the deferred application of conditions for in -house devices (OJ L 9, 28.1.2022, p. 3).  
5 In those three cases, the joint ass essment team has already reviewed the applicants’ corrective and 
preventive action plan.  The length of the overall designation process varies considerably from case to 
case. Based on data from December 2021, the average length of the overall process was 84 2 days for a 
designation in accordance with the MDR.  EN 2  EN by notified bodies to the M edical Device Coordination Group (MDCG)6 on 17 
November 2022, the number of certificates issued by May 2024 may reach around 
7,000 if the current rate of certificate issuance remains the same  with no changes to 
current conditions.  Notified bodies estimate that the transition of all Directives’ 
certificates to MDR cer tificates could possibly be completed by December 20277. 
 
 
Source: E uropean Commission, based on data provided by 30 notified bod ies in October 2022 . 
This is in stark contrast to 21,376 valid certificates issued under Council Directive 
90/385/EEC on active implantable medical devices (AIMDD)8 and Council Directive 
93/42/EEC on medical devices (MDD)9 that will expire between January 2023 and 
26 May 2024. Of those 2 1,376 certificates, 4,311 certificates will expire in 2023 and 
17,095 certificates will e xpire in the first five months of 2024. Of note,  3,509 
certificates i ssued under the AIMDD or MDD  have already expired between May 
2021 and December 2022.  
Year  of expiry  Number of expired/expiring certificates 
issued under Council Directives 
90/385/EEC and  93/42/EEC  
                                                 
6 The MDCG has been established by Article 103 of Regulation (EU) 2017/745. It is composed of 
representatives appointed by Member States and chaired by a representative of the Commission. The 
MDCG is lis ted in the Commission’s register of expert groups  with the code X03565.  
7 Based on the results of a survey among notified bodies conducted end of November/beginning of 
December 2022; the respondents represent notified bodies that have issued around 80% of all 
certificates issued under Council Directives 90/385/EEC and 93/42/EEC that were valid in October 
2022. This estimation does n ot take into account the number of first MDR certification of devices for 
which no certificates have been issued under Council Directives 90/385/EEC and 93/42/EEC and which 
require notified body involvement under the MDR.  
8 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).  
9 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).  
EN 3  EN 2021 (from 26 May)  1,139 
2022  2,370 
2023  4,311 
2024 (until 26 May 2024 ) 17,095 
Source: European Commission, based on data provided by notified bod ies in 2021 and 2022.  
After the expiry of the certificates issued  under the Directives and without a valid 
MDR certificate, manufacturers are no longer allowed to place these medical devices 
on the EU market. This may cause shortages of medical devices , putting patient 
safety at risk. It is also likely to  have a signific ant negative impact on innovation and 
business activity in the medical technology sector within the EU . The situation is 
exacerbated by the impact of the COVID -19 pandemic on clinical investigations, on -
site audits and global supply chains, on which Russia ’s war of aggression against 
Ukraine is having a further negative impact.  
The overall goal of the proposed amendments is to maintain patients’ access to a 
wide range of medical devices  while ensuring the transition to the new framework.  
The extension will be staggered depending on the risk class of the device, i.e. until 
December 2027 for devices with a higher risk and until December 2028 for medium 
and lower risk devices.  
This proposal thus aims to extend the current transition period laid down in Article 
120 of the MDR, based on certain conditions, so that only devices that are safe and 
for which manufacturers have already taken steps to transition to the MDR will 
benefit from  the additional time . This would  give manufacturers and notified bodies 
more time  to conduct the conformity assessment procedures in accordance with the 
MDR , if those  conditions are fulfilled . It also proposes to delete the ‘sell-off’ 
deadline in the relevant MDR and IVDR provision s, i.e. the end date for the further 
making available of devices which are placed on the market before or during the 
transition period and which are still in the supply chain when the extended transition 
period is over.  This would  prevent unnecessary disposal of  safe medical devices that 
are already on the ma rket but not yet with the final user.  
The extension of the transition period is complemented by an extension of the 
validity of certificates issued under the previous Council Directives 90/385/EEC and 
93/42/EEC  for the devices benefiting from the extended transition period. Also the 
validity of certificates that have already expired since 26 May 2021 would be 
extended , subject to certain conditions .  
• Consistency with existing policy provisions in the policy area  
The proposal is coherent with existing poli cy provisions as well as on -going non -
legislative actions, which will complement the proposed amendment. On 25 August 
2022, t he MDCG endorsed its position paper MDCG 2022 -1410. The paper  lays out 
19 non -legislative actions with a view to enhancing no tified body capacity, access to 
notified bodies and manufacturers’ preparedness and thereby  support a successful 
transition to the MDR and IVDR.  Several of the actions listed in MDCG 2022 -14 
                                                 
10 MDCG 2022 -14 MDCG position paper Transition to the MDR and IVDR - Notified body capacity and 
availability of medical devices and IVDs  (August 2022).  EN 4  EN have  already been implemented, such as a MDCG position paper on hybrid audits11, 
new MDCG guidance on appropriate surveillance12, and a revision of MDCG 2019 -
6, removing obstacles to the employment of qualified personnel by notified bodies13. 
On 1 December 2022, t he Commission adopted two delegated acts deferring the 
timing of the first complete re -assessment of notified bodies14. This is expected to 
free ca pacities both for designating authorities and notified bodies .  
Work  is ongoing  to implement the remaining actions  listed in MDCG 2022 -14, as 
they remain important also if the transition period is extended.  
Further a ctions  to support implementation of the two Regulations are also  (co-
)funded under the 2022 and 2023 work programmes of the EU4Health Programme15. 
On 9 December 2022, the MDCG issued its position paper  MDCG 2022 -1816 which 
sets out a uniform approach of competent authorities to applying market surveillance 
measures to bridge the gap between the expiry of MDD or AIMDD certificates and 
the issuance of MDR certificate s. That approach is meant to be a temporary measure 
until the legislative changes in this proposal take effect . It contributes to avoiding 
disruption of supply of medical devices on the EU market.  However, having regard 
to the number of certificates expiring in 2023 and 2024, it is not considered a 
sustainabl e solution for addressing the expected bottleneck of expiring certificates by 
26 May 2024.  
2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
• Legal  basis  
The proposal is based on Articles 114 and 168(4) , point (c), of the Treaty on the 
Functioning of the E uropean Union (TFEU).  
                                                 
11 MDCG 2022 -17 MDCG position paper on ‘hybrid audits’  (December 2022) . 
12 MDCG 2022 -15 Guidance on appropriate surv eillance regarding the transitional provisions under 
Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD  
(September 2022); MDCG 202 2-4 rev. 1  Guidance on appropriate surveillance regarding the 
transitional provisions under Article 120 of the MDR with regard to devices covered by certificates 
according to the MDD or the AIMDD  (December 2022) . 
13 MDCG 2019 -6 Rev.4  Questions and answers:  Requirements relating to notified bodies  (October 2022) . 
14 Commission Delegated Regulation (EU) …/... of 1.12.2022 amending Regulation (EU) 2017/745 of the 
European Parliament and of the Council as regards the frequency of complete re -assessments of notified 
bodies, C(2022) 8640, and Commission Delegated Regulation (EU) …/... of 1.12.2022 amending 
Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of 
complete re -assessments of notified bodies, C(2022) 8649. The delegated acts are available in the 
interinstitutional register of delegated acts  and are subject to a three months scrutiny procedure by the 
European Parliament and the Council.  
15 E.g. under the 2022 EU4Health Work Programme : a call for proposals aimed to foster capacity -building 
of existing and new notified bodies, to facilitate access of small and medium -sized enterprises (SMEs) 
and first -time applicants to notified bodies and to  increase preparedness of manufacturers (see HS -g-22-
19.03), various actions s upporting the implementation of Regulations on medical devices and in vitro  
diagnostic medical devices  (see HS-p-22-19.04, 06, 07, 08, 09, 10 and 11 ) and d irect grants to Member 
States’ authorities: reinforced market surveillance of medical devices and in vitro  diagnostic medical 
devices  (HS-g-22-19.01 ). Under the 2023 EU4Health Programme : support to the technical secretariat 
for Notified Bodies Coordination Group (see HS -p-23-63) and call for proposals for a program on 
orphan medical devices, in particular targeting paediatric patients (see HS -g-23-65). 
16 MDCG 2022 -18 MDCG position paper on the application of Article 97 MDR to legacy devices for 
which the MDD or AIMDD certificate expires before the issuance of a MDR certificate.  EN 5  EN • Subsidiarity  
According to the principle of subsidiarity, EU action may only be taken if the aims of 
the envisaged measure cannot be achieved by Member States alone. The legislation 
being amended was adopted at EU level in line with the subsidiarity principle and 
any amendment must be made through an act adopted by the EU legislators. In the 
case of the current proposal for an amendment, EU action is required to avoid 
disruption in the supply of devices  across the EU , to ensure the sm ooth functioning 
of the internal market, and to ensure a high level of health protection for patients and 
users . 
• Proportionality  
The proposed EU action is necessary to avert the risk of shortages of medical devices 
across the EU.  The proposed amendments aim to ensure that the intended purpose of 
the MDR and IVDR can be attained. That purpose is to establish a robust, 
transparent, predictable and sustainable regulatory framework for medical devices, 
which guarantees a high level of protection of public hea lth and patient safety and 
the smooth functioning of the internal market for these products . The proposal 
maintains the objective of both Regulation s to ensure a high level of safety and 
performance of devices by enhancing their oversight by notified bodie s. It only 
provides for the necessary additional time to achieve this objective. The proposal is 
proportionate in that it aims to address the identified issue , i.e. that due to shortage of 
notified body capacity and insufficient preparedness among manufact urers a large 
number of existing devices  may disappear from the market. Therefore, the proposed 
amendments to the MDR are limited to allowing a gradual phase -in of the 
requirements, limited to ‘legacy’ devices that need notified body involvement in the 
conformity assessment, without altering the substance of those requirements , and the 
deletion of the ‘sell -off’ deadline . The amendment of the IVDR is limited to the 
deletion of the ‘sell -off’ deadline  in order to be consistent with the proposed change 
in the  MDR . The Commission proposes to differentiate between higher risk devices 
(i.e. class III and class IIb implantable ) and lower risk devices (i.e. other class IIb, 
class IIa and class Im, Is, Ir17), with shorter transition periods for higher risk devices 
and longer periods for lower risk ones. This approach aims to balance the available 
notified body capacity  and the level of manufacturers’ preparedness  with high level 
of public health protection . 
• Choice  of the instrument  
The proposed act is a Regulation  to be adopted by the European Parliament and the 
Council, given that the act s to be amended are Regulation s adopted by the European 
Parliament and the Council.  
3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
Given the urgent nature of t his proposal , it is not accompanied by a dedicated impact 
assessment . An impact assessment was already carried out when preparing the 
proposals for the MDR and the IVDR  and t his proposal does not alter the MDR or 
IVDR in substance and doe s not impose new obligations on the concerned parties. It 
                                                 
17 Class Im means class I devi ces with a measuring function; class Is means class I devices that are placed 
on the market in sterile condition; class Ir means class I devices that are reusable surgical instruments.  EN 6  EN primarily aims to amend the transitional provisions, allowing for additional time to 
transition to the MDR ’s requirements  to avoid shortages.  The need to act quickly to 
ensure certainty ahead of the  Regulation’s current end of transition period  did not 
allow for a broad public consultation. The Commission therefore collected the 
necessary input from Member States and stakeholders through targeted exchanges.  
The initiative aims to assure that patients  throughout Europe have access to safe 
medical devices. As more and more certificates will expire before the May 2024 
deadline, the Commission has committed t o adopt a proposal in January 2023. This is 
backed up by urgent calls from the European Parliament , Member States and 
stakeholders , namely healthcare professionals , patients,  academia, scientific bodies, 
industry and notified bodies . Input from Member States and stakeholders has been 
sought through targeted interaction, mainly in the framework of the M edical Device 
Coordination Group (MDCG) with meetings on 24 -25 August, 24 -25 October and 17 
November 2022, dedicated to capacity and preparedness issues. Following a debate 
in the E uropean Parliament on 24 November 2022 (oral question O-43/2022 ), the 
European Parliament’s Committee on Environment, Public Health and Food Safety  
requested an urgent targeted amendment in a letter of 5 December 2022. An 
exchange of views with Member States took place on 9 December 2022 during the 
EPSCO Health Council18; almost all Member States took the floor and supported the 
urgent adoption of a targeted amendment of the MDR and IVDR as suggested by the 
Commission . 
The Commission will continue to closely monitor the developments and the impact 
of the proposed amendments on the market. It will also consult with the MDCG and 
stakeholders about the need for complementary actions . 
4. BUDGETARY  IMPLICATIONS  
The proposed act ion has no budgetary implications.  
5. OTHER  ELEMENTS  
• Detailed  explanation  of the specific  provisions  of the proposal  
Article 1 contains the proposed amendments to Article 120(2), (3) and (4) and to 
Article s 122 and 123 of the MDR.  Article 2 contains the amendments to Article 
110(4) and to Article 112 of the IVDR.  
• Article  1(1), point (a) , of the proposal – extension of the validity of certificates  
This provision amends Article 120(2) MDR. It extends the validity of certificates 
issued under Council Directives 90/385/EEC or 93/42/EEC that were valid on the 
day of the MDR’s date of application (26 May 2021) and have not been withdrawn 
by a notified body. The extension is direct ly applicable , so that notified bodies are 
not required t o change the date on the individual certificates. The length of the 
extension of the certificate’s validity corresponds to the length of the extended 
transition period laid down in the proposed Article 120(3 a) to (3c) of the MDR.  As 
regards certificates th at have already expired when the proposed amendment comes 
into force, the extension would be subject to the condition that, at the moment of the 
expiry, the manufacturer has signed a contract with a notified body for the 
                                                 
18 See Commission information note circulated as Council document 15520/22  of 6.12.2022.  EN 7  EN conformity assessment of the device  in question . Alternatively, if no such contract 
has been signed at the moment when the certificate expired, a national competent 
authority may have granted a derogation from the applicable conformity assessment 
procedure in accordance with Article 59 of the MDR or ha ve required the 
manufacturer to carry out the conformity assessment procedure within a specific time 
period in accordance with Article 97 of the MDR.    
• Article 1(1), point (b) , of the proposal – extension of the transition period  
This provision amends Article 120(3) MDR. Due to the length of the provision, 
paragraph 3 is replaced by paragraphs 3a to 3g. The transition period is extended 
from 26 May 2024 until 31 December 2027 for higher risk devices (class III and 
class IIb implantable devices except cer tain devices for which the MDR provides 
exemptions , given that these devices are considered to be based on  well established 
technologies ) and until 31 December 2028 for medium  and lower risk devices (other 
class IIb  devices and class IIa , class Im, Is and Ir devices).  
In the same way as the current Article 120(3)  MDR , the extended transition period 
applies only to ‘legacy devices’, i.e. those covered by a certificate or declaration of 
conformity issued under Council Directives 90/385/EEC or 93/42/EEC before  26 
May 2021.  
Moreover, the application of the extended transition period is subject to several 
cumulative conditions, which are:  
● the devices must continue to comply with Directive 90/385/EEC or Directive 
93/42/EEC, as applicable . This condition is already part of the current Article 
120(3) MDR;  
● the devices do not undergo significant changes in the design and intended 
purpose . This condition is already part of the current Article 120(3) MDR;  
● the device s do not present an unacceptable risk to the health or safety of 
patients, users or other persons, or to other aspects of the protection of public 
health . The concept of “unacceptable risk to health and safety” is set out in 
Article 94 and 95 of the MDR. No systematic check of the device’s safety is 
required, as devices covered by a certificate issued under the Directives will be 
under ‘appropriate surveillance’ by the body that issued the certificate or a 
notified body  designated under the MDR . Where, as part of their market 
surveillance activities, a competent authority finds that a device present s an 
unacceptable risk to the health or safety of patients, users or other persons, or 
to other aspects of the protection of public health , the transition period ceases 
to apply for that device;  
● no later t han 26 May  2024 , the manufacturer has put in place a quality  
management system (QMS) in accordance with A rticle 10(9) of th e MDR . This 
condition aims to ensure that manufacturers gradually move towards full 
compliance with the MDR requirements. No specific  attestation, i.e. no self -
declaration nor verification of the appropriateness of the QMS by a notified 
body, is required at this stage. However, by submitting an application for 
conformity assessment to a notified body (see next condition), the 
manufactur er implicitly confirms that its QMS is in compliance with the MDR;  
● no later than 26 May 2024, the manufacturer, or its authorised representative, 
has lodged a  formal application in accordance with Annex VII, Section 4.3, of 
the MDR  for conformity assessm ent in respect of a ‘legacy device ’ covered by EN 8  EN a Directive’s certificate  or declaration of conformity , or in  respect of a device 
intended to substitute that device  under the MDR, and no later than 26 
September 2024 the notified body and the manufacturer have signed a written 
agreement in accordance with Annex VII, Section 4.3 , of this Regulation . This 
condition aims to ensure that only devices that the manufacturer intends to 
transition to the MDR will benefit from the extended transition period. The 
extension should, however, also apply to ‘legacy devices’ that the manufacturer 
intends to replace by a ‘new’ device for which it applies for conformity 
assessment befor e 26 May 2024. In this way, unnecessary applications for 
certification of devices that will in any case be phased out and replaced by a 
new generation of devices will be avoided, whist keeping the existing models 
available until the end of the transition p eriod.  
The devices covered by a certificate issued under the AIMDD or MDD remain 
subject to ‘appropriate  surveillance’ by the notified body that issued the certificate. 
Alternatively, the manufacturer can agree with a notified body designated under the 
MDR  that the latter  becomes responsible for the surveillance . At the latest by the 
date when the written agreement between the manufacturer and the notified body for 
conformity assessment in accordance with the MDR needs to be signed, that notified 
body would  by default become responsible for the appropriate surveillance.  
The amendment introduces a transition period until 26 May 2026 also for class III 
custom -made implantable devices , which are currently not covered by Article 120(3) 
MDR. While manufacturers of class III implantable custom -made devices are 
required to comply with all applicable MDR requirements since 26 May 2021, they 
will now be given more time to obtain certification of their quality management 
system by a notified body. Also in this case, t he transition period only applies if the 
manufacturer has lodged an application before 26 May 2024  resulting in the signing 
of a contract with the notified body before 26 September  2024.  
• Article 1(1), point (c), of the proposal – deletion of the ‘sell-off’ deadline  in the 
MDR  
This provision deletes the current ‘sell -off’ date ( 27 May 2025) in  Article 120(4) 
MDR. Consequently , devices placed on the market before the end of the transition 
period can be made further available on the market without a legal time restriction.  
• Article 1(2) and (3) of the proposal – adaptation of Article s 122 and 123 MDR  
This provision adapts Article s 122 and 123 MDR to reflect the extended transition 
period and the deletion  of the ‘sell -off’ deadline . 
• Article 2(1) of the proposal – deletion of the ‘sell-off’ deadlines in the IVDR  
This provision deletes the current ‘sell -off’ dates (25 May 2025 to 26 May 2028) in 
Article 110(4) IVDR. Consequently, devices placed on the market before the end of 
the transition period laid  down in Article 110(3) IVDR can be made further available 
on the market without a legal time restriction.  
• Article 2( 2) of the proposal – adaptation of Article 112 IVDR  
This provision adapts Article 112 IVDR to reflect the deletion of the ‘sell -off’ 
deadlines . EN 9  EN 2023/0005 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional 
provisions for certain medical devices and in vitro  diagnostic medical devices  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 and Article 168(4) , point (c), thereof,  
Having regard to the proposal from the European Commission,  
After transmission of the draft legislative act to the national  parliaments,  
After consulting the European Economic and Social Committee,  
After consulting the Committee of the Regions,  
Acting in accordance with the ordinary legislative procedure , 
Whereas:  
(1) Regulation s (EU) 2017/7451 and (EU) 2017/7462 of the Europe an Parliament and of 
the Council establish a new regulatory framework to ensure the smooth functioning of 
the internal market as regards medical devices and in vitro  diagnostic medical devices , 
taking as a base a high level of protection of health for pati ents and users. At the same 
time, Regulation s (EU) 2017/745 and (EU) 2017/746 set high standards of quality and 
safety for medical devices and in vitro  diagnostic medical devices in order to meet 
common safety concerns as regards such devices. Furthermore,  both Regulation s 
significantly reinforce key elements of the previous regulatory framework in Council 
Directives 90/385/EEC3 and 93/42/EEC4 and Directive 98/79/EC of the European 
Parliament and of the Council5, such as the supervision of notified bodies, conformity 
assessment procedures, clinical evidence requirements , vigilance and market 
surveillance, whilst introducing provisions ensuring transparency and traceability 
regarding medical devices  and in vitro  diagnostic medical devices . 
                                                 
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).  
2 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro  
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 
(OJ L 117, 5.5.2017, p. 176).  
3 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating to active implantab le medical devices (OJ L 189, 20.7.1990, p. 17).  
4 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).  
5 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro  
diagnos tic medical devices (OJ L 331, 7.12.1998, p. 1).  EN 10  EN (2) Due to the impact of the COVID -19 pandemic , the date of application of Regulation 
(EU) 2017/745 has been postponed by one year to 26 May 2021  by Regulation (EU) 
2020/561 of the European Parliament and of the Council6, while t he date of 26 May 
2024 was maintained as end of the transition period by which certain devices that 
continue to comply with Directive 90/385/EEC or Directive 93/42/EEC may be placed 
on the market or put into servic e. 
(3) Also due to the impact of the COVID -19 pandemic , the transition period provided for 
in Regulation (EU) 2017/746 has already been extended by Regulation (EU) 2022/112 
of the European Parliament and of the Council7.      
(4) Despite the steady increas e in the number of notified bodies designated in accordance 
with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not 
sufficient to ensure the conformity assessment  of the large  number of devices covered 
by certificates issued under Direct ive 90/385/EEC or Directive 93/42/EEC before 26 
May 2024. It appears that a large number of manufacturers , especially small and 
medium -sized enterprises, are not sufficiently prepared to demonstrate compliance 
with the requirements of Regulation (EU) 2017/ 745, taking into account also the 
complexity of those new requirements. Therefore, i t is very likely that many devices 
that may be placed on the market in accordance with the transitional provisions 
provided for in Regulation (EU) 2017/745  are not going to  be certified in accordance 
with that Regulation before the end of the transition period, which leads to the risk of 
shortages of medical devices in the Union . 
(5) In light of reports from healthcare professionals about the imminent risk of shortages 
of devices, it is necessary , as a matter of urgency, to extend the validity of certificates 
issued under Directives 90/385/EEC and 93/42/ EEC and to extend  the transition 
period during which devices that are in conformity with those Directives can be placed  
on the market . The extension should be sufficiently long to give notified bodies the 
time needed to carry out the conformity assessments required of them. The extension  
aims at ensur ing a high level of public health protection , including patient safety  and 
an avoid ance of shortages of medical devices needed for the smooth functioning of 
health services , without lowering current quality and safety requirements . 
(6) The extension should be subject to certain conditions  to ensure that only devices that 
are sa fe and for which the manufacturers have taken steps to transition towards 
compliance with Regulation (EU) 2017/745 w ill benefit f rom the additional time . 
(7) To ensure progressive transition to Regulation (EU) 2017/745, the appropriate 
surveillance regarding devices benefiting from the transition period  should eventually 
pass over from the body that has issued the certificate in accordance with Directive 
90/385/EEC or Directive  93/42/EEC to a notified body designated under Regulation 
(EU) 2017/745. For reasons of legal certainty it should be provided t hat the notified 
body should not be responsible for conformity assessment and surveillance activities 
carried out by the o utgoing body.        
                                                 
6 Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending 
Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its 
provision s (OJ L 130, 24.4.2020, p. 18).  
7 Regulation (EU) 2022/112 of the European Parliament and of the Council of 25  January 2022 amending 
Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro  diagnostic medical 
devices and the deferred application of conditions for in -house devices  (OJ L 19, 28.1.2022, p. 3 ). EN 11  EN (8) As regards the period of time needed to allow manufacturers and notified bodies to 
carry out the conformity assessment in accordance with Regulation (EU) 2017/745 of 
medical devices that had been CE marked in accordance with Direct ive 90/385/EEC or 
Directive 93/42/EEC , a balance should be struck between the limited available 
capacity of notified bodies and ensuring a high level of patient safety and public health 
protection. Therefore, the length of the transition period should depe nd on the risk 
class of the medical device s concerned, so that the period is shorter for devices 
belonging to a higher risk class and longer for devices belonging to a lower risk class . 
(9) Contrary to Directive s 90/385/EEC and 93/42/EEC, Regulation (EU) 2017/745 
requires the involvement of a notified body in the conformity assessment of class III 
custom -made implantable devices. Havi ng regard to insufficient notified body 
capacity and the fact that manufacturers of custom -made devices are often small or 
medium -sized enterprises that did not have access to a notified body under Directive s 
90/385/EEC and 93/42/EEC, a transition period should be provided during which class 
III custom -made implantable devices may be placed on the ma rket or put into service 
without a certificate issued by a notified body .     
(10) Article 120(4) of Regulation (EU) 2017/745 and Article 110(4) of Regulation (EU) 
2017/746 prohibit the further making available of devices which are placed on the 
market by the end of the applicable transition period and which are still in the supply 
chain one year after the end of th at transition period. To prevent unnecessary disposal 
of safe medical devices and in vitro  diagnostic medical devices that are still in the 
supp ly chain, thus adding to the imminent risk of shortages of devices, such further 
making available of devices should be unlimited in time . 
(11) The adoption of this Regulation takes place due to  exceptional circumstances arising 
from an imminent  risk of shortages of medical devices and the associated risk of a 
public health crisis. In order  to attain the intended effect of the amendments to 
Regulation s (EU) 2017/745  and (EU) 2017/746  and to ensure availability of devices 
whose certificates have a lready expired or are due to expire before 26 May 2024 , to 
provide legal certainty for economic operators and healthcare providers , and for 
reasons of consistency as regards the amendments to both Regulations,  it is necessary 
for this Regulation to enter into force as soon as possible . For the same reasons i t is 
also considered appropriate to provide for an exception to the eight -week period 
referred to in Article  4 of Protocol No  1 on the role of national Parl iaments  in the 
European Union, annexed to the Treaty on European Union , to the Treaty on the 
Functioning of the European Union and to the Treaty establishing the European 
Atomic Energy Community , 
HAVE ADOPTED THIS REGULATION:  
Article 1  
Regulation (EU) 2017/745 is amended as follows:  
(1) Article 120 is amended as follows:  
(a) in paragraph 2, the second subparagraph is  replaced by the follow ing: 
‘Certificates issued by notified bodies in accordance with Directives  
90/385/EEC and 93/42/EEC as from  25 May 2017  that were valid on 26 May 
2021  and that have not been withdrawn afterwards  shall remain  valid after the 
end of the period indicated on the certificate until the dates set out in paragraph 
3b for the relevant risk class  of the devices . Certificates referred to in the first EN 12  EN sentence  that have expired before [OP please insert the date – date of entry 
into force of this Regulation ] shall be considered to be valid until the dates set 
out in paragraph 3b  only if one of the following  conditions is fulfilled:  
(a) before the date of expiry of the certificate, the manufacturer and a 
notified body have signed a written agreement in accordance with 
Section 4.3 , second subparagraph,  of Annex VII  for the conformity 
assessment in respect of the device covered by the expired certificate or 
in respect of a device intended to substitute that device ;  
(b) a competent authority of a Member State has granted a derogation from 
the applicable conformity assessment procedure in accordance with 
Article 59(1) or has required the  manufacturer , in accordance with 
Article 97(1), to carry out the applicable conformity assessment 
procedure’ ; 
(b) paragraph 3 is replaced by the follow ing: 
‘3a. By way of derogation from Article 5 and provided the conditions set out in 
paragraph  3d of this Article  are met , devices referred to in paragraph s 3b and 
3c of this Article  may be placed on the market or put into service until the dates  
set out in those paragraphs.  
3b. Devices which have a certificate that was issued in accordance with 
Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of 
paragraph 2 of this Article  may be placed on the market or put into service 
until the following dates:  
(a) 31 December  2027, for class III devices and for class IIb implantable 
devic es, except sutures, s taples, dental fillings, dental braces, tooth 
crowns, screws, wedges, plates, wires, pins, clips and connectors ; 
(b) 31 December  2028, for class IIb devices other than those covered by 
point (a), for class IIa devices , and for class I devices placed on the 
market in sterile condition or having a measuring function.  
3c. Devices for which the conformity assessment procedure pursuant to 
Directive 93/42/EEC did not require the involvement of a notified body, for 
which the declaration of con formity was drawn up prior to 26 May 2021 and 
for which the conformity assessment procedure pursuant to this Regulation 
requires the involvement of a notified body, may be placed on the market or 
put into service until 31 December 2028 . 
3d. Devices may be placed on the market or put into service until the dates 
referred to in paragraph s 3b and 3c of this Article only if the following 
conditions are met:  
(a) those devices continue to comply with Directive 90/385/EEC or 
Directive 93/42/EEC, as applicab le; 
(b) there are no significant changes in the design and intended purpose ; 
(c) the device s do not present an unacceptable risk to the health or safety of 
patients, users or other persons, or to other aspects of the protection of 
public health ; 
(d) no lat er than 26 May  2024 , the manufacturer has put in place a quality  
management system in accordance with A rticle 10(9);  EN 13  EN (e) no later than 26 May 2024, the manufacturer, or an authorised 
representative, has lodged a  formal application in accordance with 
Section 4.3 , first subparagraph, of Annex VII for conformity assessment 
in respect of a device referred to in paragraph s 3b and 3c of this Article 
or in respect of a device intended to substitute that device , and no later 
than 26 September  2024 the notifie d body and the manufacturer have 
signed a written agreement in accordance with Section 4.3 , second 
subparagraph, of Annex VII . 
3e. By way of derogation from paragraph  3a, the requirements of this 
Regulation relating to post -market surveillance, market surveillance, vigilance, 
registration of economic operators and of devices shall apply to devices 
referred to in paragraph s 3b and 3c  of this Article  in place  of the correspond ing 
requirements in Directives  90/385/EEC and 93/42/EEC . 
3f. Without prejudice to Chapter  IV and paragraph  1 of this Article, the 
notified body that issued the certificate referred to in paragraph  3b of this 
Article  shall continue to be responsible for the  appropriate surveillance in 
respect of the applicable requirements relating to the devices it has certified , 
unless the manufacturer has agree d with a notified body designated in 
accordance with Article 42 that the latter shall  carry out that surveillance .  
No later than 26 September 2024 , the notified body that has signed the written 
agreement referred to in paragraph  3d, point (e), shall be responsible for the 
surveillance in respect of the device s covered by the written agreement . Where 
the written agreement covers a device intended to substitute a device  which has 
a certificate that was issued in accordance with Directive 90/385/EEC or 
Directive 93/42/EEC , the surveillance shall be conducted in respect of the 
device that is being substituted .  
The arrangements for the transfer of the surveillance from the notified body 
that issued the certificate  to the notified body designated in accordance with 
Article 42 shall be defined in an agreement between the manufacturer, the 
notified body designate d in accordance with Article 42  and, where practicable, 
the notified body  that issued the certificate . The notified body designated in 
accordance with Article 42 shall not be responsible for conformity assessment 
activities carried out by the notified  body  that issued the certificate .        
3g. By way of derogation from Article 5 , class III custom -made implantable 
devices may be placed on the mar ket or put into service until 26 May 202 6 
without a certificate issued by a notified body  in accordance with the 
conformity assessment procedure referred to in Article 5 2(8), second 
subparagraph,  provided that no later than 26 May 2024, the manufacturer, or 
the authorised representative  of the manufacturer , has lodged a  formal 
application in a ccordance with Section 4.3 , first subparagraph, of Annex VII  
for the applicable conformity assessment , and no later than 26 September  2024 
the notified body and the manufacturer have signed a written agreement in 
accordance with Section 4.3 , second subpara graph, of Annex VII .’; 
(c) paragraph 4 is replaced by the following:  
‘4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC 
and 93/42/EEC prior to 26 May 2021, and devices placed on the market from EN 14  EN 26 May 2021 pursuant to paragraphs 3a , 3b, 3c and 3g of this Article, may 
continue to be made available on the market or put into service.’  
(2) Article 122 is amended as follows:  
(1) in the first paragraph, the introductory wording is replaced by the following:  
‘Without prejudice to Article 120(3a) to (3 f) and (4) of this Regulation, and 
without prejudice to the obligations of the Member States and manufacturers as 
regards vigilance and to the obligations of manufacturers as regards the making 
available of documentation, under Directives 90/38 5/EEC and 93/42/EEC, 
those Directives are repealed with effect from 26 May 2021 , with the exception 
of:’; 
(2) the second paragraph is replaced by the following : 
‘As regards the devices referred to in Article  120(3 a) to (3 f) and (4)  of this 
Regulation, the Directives referred to in the first  paragraph  shall continue to 
apply to the extent necessary for the application of th ose paragraph s.’; 
(3) In Article 123(3), point (d), the twenty -fourth  indent is replaced by the following:  
‘- Article 120(3e).’.  
Article 2 
Regulation (EU) 2017/746 is amended as follows:  
(1) in Article 110, paragraph 4 is replaced by the following:  
‘4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 
May 2022, and devices lawfully placed on the market from 26  May 2022 pursuant to 
paragraph 3 of this Article may continue to be made available on the market or put 
into service.’;  
(2) in Article 112 , the second paragraph is replaced by the following : 
‘As regards the devices referred to in Article 110(3)  and (4)  of this Regulation, 
Directive 98/79/EC shall continue to apply to the extent necessary for the application 
of those paragraph s.’. 
Article  3 
This Regulation shall enter into force on the day of its publication in the Official Journal of 
the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President