Search Legislation

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020

 Help about what version

What Version

  • Latest available (Revised)
  • Original (As made)
 Help about opening options

Opening OptionsExpand opening options

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Amendment of regulation 3(3)

This section has no associated Explanatory Memorandum

4.  In regulation 3(3)—

(a)after sub-paragraph (a) insert—

(aa)after the definition of “active implantable medical device” insert—

“approved body” is to be construed in accordance with regulation A45;;;

(b)for sub-paragraph (c) substitute—

(c)omit the definition of “authorised representative”;;

(c)after sub-paragraph (d) insert—

(da)omit the definition of “the Community”;;

(d)in sub-paragraph (e) for “exit day” substitute “IP completion day”;

(e)in sub-paragraph (f) for “exit day” substitute “IP completion day”;

(f)in sub-paragraph (g) for “exit day” substitute “IP completion day”;

(g)after paragraph (j) insert—

(h)“(ja) omit the definition of “European Economic Area”;”;

(i)in sub-paragraph (l), for “the United Kingdom” substitute “Great Britain”;

(j)for sub-paragraph (q) substitute—

(q)omit the definition of “notified body”;;

(k)in sub-paragraph (r)(i) for “United Kingdom” substitute “Great Britain”;

(l)in sub-paragraph (s) for “for “Community” substitute “United Kingdom”” substitute “for “the Community” substitute “Great Britain””;

(m)after sub-paragraph (u) insert—

(ua)after the definition of “third country conformity assessment body” insert—

“UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008(1);;;

(n)for sub-paragraph (v) substitute—

(v)omit the definition of “UK notified body”;;

(o)in sub-paragraph (w) in the definition of “UK responsible person” inserted by sub-paragraph (w), after “established in” insert “any part of”.

(1)

Article 2(22) was inserted into Regulation (EC) No 765/2008 by paragraph 3 of Schedule 33 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696). This Regulation was incorporated into domestic law by section 3 of the European Union Withdrawal Act 2018 c. 16.

Back to top

Options/Help

You have chosen to open The Whole Instrument

The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open The Whole Instrument as a PDF

The Whole Instrument you have selected contains over 200 provisions and might take some time to download.

Would you like to continue?

You have chosen to open the Whole Instrument

The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?