On 20 March 2023, an amendment to the Medical Device Regulation was published in the Official Journal of the European Union, extending the validity of certificates for medical devices issued under the earlier regulations. The amendment was adopted as a matter of urgency and went into effect immediately (on the date of publication). The extension is intended to prevent shortages of medical devices on the market.
Need for change
According to the recitals in the amendment, the transitional provisions currently in place provided for too-short periods for maintaining the validity of certificates issued under the old rules, i.e. under the Medical Device Directives (MDD—Directive 93/42/EEC and Directive 90/385/EEC).
Although there is an increasing number of notified units issuing new certificates in accordance with the Medical Device Regulation (MDR—2017/745), their capacity is insufficient to meet demand. This raised concerns that many safe devices would not manage to gain market access before the end of the transition period.
Shortages of medical devices would entail obvious harm to patients’ health. The desire to avoid this harm was the impetus for the regulatory change.
What are the requirements for taking advantage of an extension?
The extension applies to certificates issued by MDD-notified units between 25 May 2017 and 26 May 2021 (i.e. the effective date of MDR) and not revoked after that date.
If such certificates expired between 27 May 2021 and 19 March 2023, they can only benefit from reinstatement and renewal if:
- Before expiration of the certificate, the manufacturer signed a contract for certification of the product under the new rules with a notified unit, or
- The relevant state authority granted a derogation from the need to conduct a conformity assessment for the sake of patient welfare pursuant to Art. 59 MDR, or required the manufacturer to carry out the conformity assessment procedure pursuant to Art. 97(1) MDR.
The requirements for taking advantage of the extension are as follows:
- The devices continue to comply with MDD.
- There are no significant changes in design and intended use.
- The devices do not pose an unacceptable risk to patients’ health or safety, users or other persons, or other public health issues.
- No later than 26 May 2024, the manufacturer implements a quality management system in accordance with MDR.
- No later than 26 May 2024, the manufacturer or authorised representative formally files an application to a notified unit in accordance with MDR to conduct a conformity assessment for the device or a device intended to replace the device, and no later than 26 September 2024, the notified unit and the manufacturer sign a written agreement in accordance with MDR.
Certificates for Class III medical devices and Class IIb implantable devices, except for sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clamps and abutments, will be valid until 31 December 2027 (provided they meet the foregoing requirements).
Certificates for the remaining Class IIb devices (other than those valid until the end of 2027), Class IIa devices, and Is and Im devices will be valid until 31 December 2028 (subject to compliance with the foregoing requirements).
Additionally, until 31 December 2028, devices that were not subject to a conformity assessment procedure involving a notified unit under MDD but are subject to it under MDR may be placed on the market or put into use, as long as a declaration of conformity was drawn up before the effective date of MDR (i.e. before 26 May 2021).
Removal of end date from sell-off clause
The amendment also includes a modification of the sell-out clause, under both MDR and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The essence of the sell-out clause is the possibility for a device that was put on the market pursuant to MDD or Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), or under the transitional provisions of MDR/IVDR, to remain on the market.
Until now, the provisions established a deadline by which a device that was previously legally put on the market under the foregoing rules could continue to be marketed or put into use. The amendment abolished this deadline, which means that a product introduced under the old or transitional rules can remain on the market (i.e. be made available on the market or put into use) without time limits.
Joanna Krakowiak, attorney-at-law, Marcin Rytel, M&A and Corporate practice, Life Science & Healthcare practice, Wardyński & Partners