European Parliament

2019-2024

Plenary sitting

cor02

13.11.2019

CORRIGENDUM
to 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)

(position of the European Parliament adopted at second reading on 5 April 2017 with a view
to the adoption of the above regulation
P8_TA(2017)0107)
(10728/4/2016 – C8-0104/2017 – 2012/0266(COD))

In accordance with Rule 241 of the European Parliament's Rules of Procedure, the above
regulation is corrected as follows:

On page 69, point (c) of Article 78(8)

for:

'(c) considerations as regards subject safety and data reliability and robustness submitted
under point (b) of paragraph 4.',

read:

'(c) considerations as regards subject safety and data reliability and robustness submitted
under point (d) of paragraph 4.'.

On page 89, Article 120(3):

for:

'3. By way of derogation from Article 5 of this Regulation, a device with a certificate that
was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and

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 which is valid by virtue of paragraph 2 of this Article may only be placed on the
market or put into service provided that from the date of application of this Regulation
it continues (…)',

read:

'3. By way of derogation from Article 5 of this Regulation, a device which is a class I
device pursuant to Directive 93/42/EEC, for which the declaration of conformity was
drawn up prior to 26 May 2020 and for which the conformity assessment procedure
pursuant to this Regulation requires the involvement of a notified body, or which has a
certificate that was issued in accordance with Directive 90/385/EEC or Directive
93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on
the market or put into service until 26 May 2024, provided that from 26 May 2020 it
continues (…)'.

On page 89, Article 120(4):

for:

'(…) on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2
of this Article, may continue to be made available on the market or put into service until 27
May 2025.',

read:

'(…) on the market from 26 May 2020 pursuant to paragraph 3 of this Article, may continue
to be made available on the market or put into service until 26 May 2025.'.

On page 90, Article 120(8):

for:

'8. By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive
90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of
Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified
bodies which, during the period starting on the later of the dates referred to point (d) of
Article 123(3) and ending 18 months later, comply with Article 29(4) and Article 56(5)
of this Regulation shall be considered to comply with the laws and regulations adopted
by Member States in accordance with, respectively, Article 10a of Directive

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 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and with, respectively,
point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article
14a(1) of Directive 93/42/EEC as specified in Decision 2010/227/EU.',

read:

'8. By way of derogation from Article 10a, point (a) of Article 10b(1) and Article 11(5) of
Directive 90/385/EEC and Article 14(1) and (2), points (a) and (b) of Article 14a(1)
and Article 16(5) of Directive 93/42/EEC, manufacturers, authorised representatives,
importers and notified bodies which, during the period starting on the later of the dates
referred to point (d) of Article 123(3) and ending 18 months later, comply with
Articles 29(4), 31(1) and 56(5) of this Regulation shall be considered to comply with
the laws and regulations adopted by Member States in accordance with, respectively,
Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC,
with, respectively, point (a) of Article 10b(1) of Directive 90/385/EEC or points (a)
and (b) of Article 14a(1) of Directive 93/42/EEC and with, respectively, Article 11(5)
of Directive 90/385/EEC or Article 16(5) of Directive 93/42/EEC, as specified in
Decision 2010/227/EU.'.

On page 90, Article 122, second indent:

for:

'— Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC, and (…)',

read:

'— Article 10a, point (a) of Article 10b(1) and Article 11(5) of Directive 90/385/EEC, and
(…)'.

On page 91, Article 122, fourth indent:

for:

'— Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC,
and (…)',

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 read:

'— Article 14(1) and (2), points (a) and (b) of Article 14a(1) and Article 16(5) of
Directive 93/42/EEC, and (…)'.

On page 112, Annex III, Section 1.1, point (b), fifth bullet point

for:

'— methods and protocols to manage the events subject to the trend report (…)',

read:

'— methods and protocols to manage the incidents subject to the trend report (…)'.

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